Relationship between Lipoprotein(a) and cardiovascular risk factors-data from 4602 participants of the ELITE study.

Lipoprotein(a) (Lp(a)) is becoming increasingly important as an independent risk factor for cardiovascular disease. Since no effective therapy currently exists other than lipid apheresis, the recommendation remains to optimally adjust all other cardiovascular risk factors (CVRF). In a Northwest German population study, the frequency of elevated Lp(a) levels and all other CVRF was investigated. The aim was to investigate whether individuals with elevated Lp(a) levels were also more likely to have other CVRFs. To date, 4602 individuals have been enrolled in the study, and blood pressure, weight, lipids, diabetes, medications, and pre-existing conditions were recorded in addition to Lp(a). In addition, questionnaires assessed physical activity, psychological stress, depression, and brain dysfunction. All participants received detailed individual recommendation about their CVRF and its treatment. In the further follow-up of 5 years, it will be examined how persons with elevated Lp(a) implemented these recommendations in comparison with participants without elevated Lp(a). The first group Lp(a) <75 nmol/L consisted of 3550 (80.2%), the Lp(a) 75-120 nmol/L group of 341 (7.4%) and the Lp(a) >120 nmol/L of 538 (11.7%). 81.6% of all participants had one or more CVRF. Age, sex, and prevalence of hypertension, diabetes, smoking, obesity, and exercise did not differ among the 3 groups. As expected, LDL-Cholesterol was significantly elevated in the Lp(a) >120 nmol/L group despite significantly more frequent use of statins. Significantly more often hypertensive patients were found in the Lp(a) >120 nmol/L group who were inadequately controlled by medication and significantly less often persons without further CVRF. No differences existed in the frequency of psychological stress, depression, and mild cognitive impairment. CVRF occur with comparable frequency in individuals with elevated Lp(a) levels. However, individuals with Lp(a) above 120 nmol/L were more likely to have poorly controlled blood pressure, elevated LDL-C, and less likely to have no other risk factors. This underlines that in case of Lp(a) elevation all further CVRF should be intensively adjusted, especially in case of strongly elevated values >120 nmol/L. However, these recommendations have not been adequately implemented in clinical care in this population to date.

Influence of individualized prevention recommendations after one year on the control of hypertension in 3,868 follow-up participants of the ELITE study.

OBJECTIVES: The ELITE study (German acronym for "Nutrition, lifestyle and individual information for prevention of heart attack, stroke and dementia") prospectively collects data on hypertension, cardiovascular risk factors (RF), dietary habits, physical activity, cognitive function, and quality of life in North-West Germany, which will then be improved through targeted individual information. The aim of the study is to improve the health of the participants in the long term and to identify reasons for a lack of implementation of prevention measures. METHODS: Of 4,602 included subjects, 3,868 could be studied so far at one-year follow-up. Blood pressure (BP) was measured according to the guidelines at admission and blood pressure history, premedication, sports behaviour and BMI were recorded by means of questionnaires and compared with the data collected in the follow-up examination after one year. RESULTS: The participants were evaluated in 4 groups (G): G1 - normotensive patients (n = 1,558), G2 - controlled hypertensive patients (n = 502), G3 - untreated uncontrolled hypertensive patients (n = 1,080), G4 - treated uncontrolled hypertensive patients (n = 728). In G1 blood pressure (RR) remained unchanged from 126.3/77.8 to 127.8/78.5, in G2 there was a significant (p < 0.001) RR increase from 128.1/77.0 to 134.9/79.8. In G3 and G4 RR decreased significantly (p < 0.001) from 149.9/90.0 to 143.5/86.9 and from 153.1/87.5 to 146.2 84.1 mmHg, respectively. In G3 and G4, RR decreased in 56.1% and 56.3% of subjects and increased in 18% and 21%, respectively. In contrast, RR increase was found more frequently in G1 and G2 (34.3% and 51%, respectively), and RR decrease less frequently (25.4 and 20.7%, respectively). The main reasons for RR decrease were weight loss, more exercise, and more antihypertensives. Frequently, improved compliance and dietary changes were given as reasons. As expected, the opposite often led to RR increase. CONCLUSION: 56% of the hypertensive participants succeeded in lowering their blood pressure, whereas there was a significant increase in blood pressure, especially in those who were well controlled with antihypertensives. This underlines the need to further motivate normotensive patients to maintain their normotension. The results show that the combination of individual written education and lifestyle interventions are an effective tool for the public health sector to combat hypertension. In our participants, lifestyle interventions have a significant impact on BP change. It should be noted critically that there are still too many patients who have not been reached.

[Influence of the Corona pandemic on cardiovascular risk factors - Data from 1775 participants of the ELITE study before and during the Corona pandemic]. / Einfluss der Corona-Pandemie auf kardiovaskuläre Risikofaktoren ­ Daten von 1775 Teilnehmern der ELITE Studie vor und während der Corona Pandemie.

BACKGROUND: The COVID-19 pandemic and its interventions have led to a deficit in medical care and changes in people's lifestyles, which has consequently changed cardio- and cerebrovascular primary and secondary prevention. The existing data are mainly based on surveys. In addition to the problem of the accuracy of self-assessments, the pandemic per se and the massive public reporting may have biased the data.Only a few publications have compared data collected before the pandemic with results during the pandemic. The ELITE study has regularly monitored risk factors (RF) and psychosocial parameters (stress, depression, well-being, diet, brain performance, exercise) in over 5000 participants for years. From this study, data were analyzed from 1775 individuals collected before the onset and again during the pandemic (06/05/2020-25/01/2022). Thus, baseline values were unaffected by the pandemic. RESULTS: As expected, both improvements and worsening of the collected parameters were found. Blood pressure and depressive symptoms worsened significantly more often, with women more frequently affected. Weight and stress levels also increased more often than they improved. Only physical activity showed a slight increase. 24.1 % showed only deteriorations and no improvements in these parameters. In contrast, 19.6 % showed improvements exclusively. In the group with only worsening, there was a significant increase in individuals with the risk factors (RF) hypertension, obesity, elevated LDL cholesterol, nicotine, and diabetes mellitus. This resulted in an increase in individuals with 2 or more RF. In contrast, the number of individuals with 2 and more RF decreased in the group with only improvements. Strikingly, individuals with risk factors improved more frequently. CONCLUSION: A not insignificant part of the population experienced significant worsening of RF during the pandemic. This particularly affected blood pressure and depressive symptoms, and more often women.

Effects of baroreflex activation therapy on cardiac function and morphology.

AIMS: Arterial hypertension (aHTN) plays a fundamental role in the pathogenesis and prognosis of heart failure with preserved ejection fraction (HFpEF). The risk of heart failure increases with therapy-resistant arterial hypertension (trHTN), defined as inadequate blood pressure (BP) control ≥140/90 mmHg despite taking ≥3 antihypertensive medications including a diuretic. This study investigates the effects of the BP lowering baroreflex activation therapy (BAT) on cardiac function and morphology in patients with trHTN with and without HFpEF. METHODS: Sixty-four consecutive patients who had been diagnosed with trHTN and received BAT implantation between 2012 and 2016 were prospectively observed. Office BP, electrocardiographic and echocardiographic data were collected before and after BAT implantation. RESULTS: Mean patients' age was 59.1 years, 46.9% were male, and mean body mass index (BMI) was 33.2 kg/m2. The prevalence of diabetes mellitus was 38.8%, atrial fibrillation was 12.2%, and chronic kidney disease (CKD) stage ≥3 was 40.8%. Twenty-eight patients had trHTN with HFpEF, and 21 patients had trHTN without HFpEF. Patients with HFpEF were significantly older (64.7 vs. 51.6 years, P < 0.0001), had a lower BMI (30.0 vs. 37.2 kg/m2, P < 0.0001), and suffered more often from CKD-stage ≥3 (64 vs. 20%, P = 0.0032). After BAT implantation, mean office BP dropped in patients with and without HFpEF (from 169 ± 5/86 ± 4 to 143 ± 4/77 ± 3 mmHg [P = 0.0019 for systolic BP and 0.0403 for diastolic BP] and from 170 ± 5/95 ± 4 to 149 ± 6/88 ± 5 mmHg [P = 0.0019 for systolic BP and 0.0763 for diastolic BP]), while a significant reduction of the intake of calcium-antagonists, α2-agonists and direct vasodilators, as well as a decrease in average dosage of ACE-inhibitors and α2-agonists could be seen. Within the study population, a decrease in heart rate from 74 ± 2 to 67 ± 2 min-1 (P = 0.0062) and lengthening of QRS-time from 96 ± 3 to 106 ± 4 ms (P = 0.0027) and QTc-duration from 422 ± 5 to 432 ± 5 ms (P = 0.0184) were detectable. The PQ duration was virtually unchanged. In patients without HF, no significant changes of echocardiographic parameters could be seen. In patients with HFpEF, posterior wall diameter decreased significantly from 14.0 ± 0.5 to 12.7 ± 0.3 mm (P = 0.0125), left ventricular mass (LVM) declined from 278.1 ± 15.8 to 243.9 ± 13.4 g (P = 0.0203), and e' lateral increased from 8.2 ± 0.4 to 9.0 ± 0.4 cm/s (P = 0.0471). CONCLUSIONS: BAT reduced systolic and diastolic BP and was associated with morphological and functional improvement of HFpEF.

Health football beats them all: subgroup analysis of the 3F (Fit&Fun with Football) study on white-coat hypertension, sustained hypertension, dippers, nondippers, and on pharmacologically un(treated) arterial hypertension.

BACKGROUND: The 3F study (Fit&Fun with Football) demonstrated a significant reduction in blood pressure, antihypertensive medication, body weight, stress and depression through health football. Health football could be a popular tool to unleash the full preventive potential of physical activity. This work analyses the effect of health football on hypertensive subgroups: dipper, nondipper, white-coat hypertension (WCH), sustained hypertension, (un)treated hypertensive patients (UH, TH). METHODS: A prospective interventional study with 1-year follow-up. Football group (FG): n  = 103, 'health'-football training (1×/week, 90 min) led by licensed football coaches. Physical inactive, hypertensive patients older than 45 years were compared with a control group (CG) ( n  = 105). Subgroups were divided by ambulatory blood pressure monitoring (ABPM), casual blood pressure (CBP), medication schedule and compared by blood pressure (BP), laboratory results and weight. RESULTS: In all three subgroups (WCH vs. sustained hypertension, TH vs. UH, D vs. ND), health football reduced BP and weight significantly compared with the CG, and compared with the admission. An even greater effect in CBP was found in people with WCH than in sustained hypertension (FG: WCH: 141-127 mmHg, sustained Hypertension (SH): 142-132 mmHg; CG: WCH: 141-143 mmHg, SH: 140-141 mmHg). In contrast, the significant reduction in CBP and ABPM was comparable in treated and untreated patients, although antihypertensive drugs were reduced significantly more frequently in FG than in CG. BP reduction in nondippers and dippers was also comparable. In the nondipper group, nocturnal BP was significantly reduced in the FB (122.0-111.5 mmHg), but not in the CG or the dippers. CONCLUSION: All evaluated football subgroups achieved a significant BP reduction (compared with CG). This applied to dipper, nondipper, (un)treated hypertension, WCH and SH. All mentioned subgroups displayed a clear benefit. The even greater reduction in BP in WCH demonstrates the importance of physical activity before the additional prescription of antihypertensive medications, underscoring the recommendations of the ESC and ISH in WCH.

Urinary Dickkopf-3 (DKK3) Is Associated with Greater eGFR Loss in Patients with Resistant Hypertension.

Patients with resistant hypertension (HTN) demonstrate an increased risk of chronic kidney disease and progression to end-stage renal disease; however, the individual course of progression is hard to predict. Assessing the stress-induced, urinary glycoprotein Dickkopf-3 (uDKK3) may indicate ongoing renal damage and consecutive estimated glomerular filtration rate (eGFR) decline. The present study aimed to determine the association between uDKK3 levels and further eGFR changes in patients with resistant HTN. In total, 31 patients with resistant HTN were included. Blood pressure and renal function were measured at baseline and up to 24 months after (at months 12 and 24). uDKK3 levels were determined exclusively from the first available spot urine sample at baseline or up to a period of 6 months after, using a commercial ELISA kit. Distinctions between different patient groups were analyzed using the unpaired t-test or Mann-Whitney test. Correlation analysis was performed using Spearman's correlation. The median uDKK3 level was 303 (interquartile range (IQR) 150-865) pg/mg creatinine. Patients were divided into those with high and low eGFR loss (≥3 vs. <3 mL/min/1.73 m²/year). Patients with high eGFR loss showed a significantly higher median baseline uDKK3 level (646 (IQR 249-2555) (n = 13) vs. 180 (IQR 123-365) pg/mg creatinine (n = 18), p = 0.0412 (Mann-Whitney U)). Alternatively, patients could be classified into those with high and low uDKK3 levels (≥400 vs. <400 pg/mg creatinine). Patients with high uDKK3 levels showed significantly higher eGFR loss (-6.4 ± 4.7 (n = 11) vs. 0.0 ± 7.6 mL/min/1.73 m2/year (n = 20), p = 0.0172 (2-sided, independent t-test)). Within the entire cohort, there was a significant correlation between the uDKK3 levels and change in eGFR at the latest follow-up (Spearman's r = -0.3714, p = 0.0397). In patients with resistant HTN, high levels of uDKK3 are associated with higher eGFR loss up to 24 months later.

The angiotensin-receptor blocker candesartan for treatment of acute stroke (SCAST): a randomised, placebo-controlled, double-blind trial.

BACKGROUND: Raised blood pressure is common in acute stroke, and is associated with an increased risk of poor outcomes. We aimed to examine whether careful blood-pressure lowering treatment with the angiotensin-receptor blocker candesartan is beneficial in patients with acute stroke and raised blood pressure. METHODS: Participants in this randomised, placebo-controlled, double-blind trial were recruited from 146 centres in nine north European countries. Patients older than 18 years with acute stroke (ischaemic or haemorrhagic) and systolic blood pressure of 140 mm Hg or higher were included within 30 h of symptom onset. Patients were randomly allocated to candesartan or placebo (1:1) for 7 days, with doses increasing from 4 mg on day 1 to 16 mg on days 3 to 7. Randomisation was stratified by centre, with blocks of six packs of candesartan or placebo. Patients and investigators were masked to treatment allocation. There were two co-primary effect variables: the composite endpoint of vascular death, myocardial infarction, or stroke during the first 6 months; and functional outcome at 6 months, as measured by the modified Rankin Scale. Analyses were by intention to treat. The study is registered, number NCT00120003 (ClinicalTrials.gov), and ISRCTN13643354. FINDINGS: 2029 patients were randomly allocated to treatment groups (1017 candesartan, 1012 placebo), and data for status at 6 months were available for 2004 patients (99%; 1000 candesartan, 1004 placebo). During the 7-day treatment period, blood pressures were significantly lower in patients allocated candesartan than in those on placebo (mean 147/82 mm Hg [SD 23/14] in the candesartan group on day 7 vs 152/84 mm Hg [22/14] in the placebo group; p<0·0001). During 6 months' follow-up, the risk of the composite vascular endpoint did not differ between treatment groups (candesartan, 120 events, vs placebo, 111 events; adjusted hazard ratio 1·09, 95% CI 0·84-1·41; p=0·52). Analysis of functional outcome suggested a higher risk of poor outcome in the candesartan group (adjusted common odds ratio 1·17, 95% CI 1·00-1·38; p=0·048 [not significant at p≤0·025 level]). The observed effects were similar for all prespecified secondary endpoints (including death from any cause, vascular death, ischaemic stroke, haemorrhagic stroke, myocardial infarction, stroke progression, symptomatic hypotension, and renal failure) and outcomes (Scandinavian Stroke Scale score at 7 days and Barthel index at 6 months), and there was no evidence of a differential effect in any of the prespecified subgroups. During follow-up, nine (1%) patients on candesartan and five (<1%) on placebo had symptomatic hypotension, and renal failure was reported for 18 (2%) patients taking candesartan and 13 (1%) allocated placebo. INTERPRETATION: There was no indication that careful blood-pressure lowering treatment with the angiotensin-receptor blocker candesartan is beneficial in patients with acute stroke and raised blood pressure. If anything, the evidence suggested a harmful effect. FUNDING: South-Eastern Norway Regional Health Authority; Oslo University Hospital Ullevål; AstraZeneca; Takeda.

Ramipril-based versus diuretic-based antihypertensive primary treatment in patients with pre-diabetes (ADaPT) study.

BACKGROUND: Previous randomized controlled trials demonstrated a protective effect of renin angiotensin system blocking agents for the development of type-2 diabetes in patients with pre-diabetes. However, there are no real-world data available to illustrate the relevance for clinical practice. METHODS: Open, prospective, parallel group study comparing patients with an ACE inhibitor versus a diuretic based treatment. The principal aim was to document the first manifestation of type-2 diabetes in either group. RESULTS: A total of 2,011 patients were enrolled (mean age 69.1±10.3 years; 51.6% female). 1,507 patients were available for the per-protocol analysis (1,029 ramipril, 478 diuretic group). New-onset diabetes was less frequent in the ramipril than in the diuretic group over 4 years. Differences were statistically different at a median duration of 3 years (24.4% vs 29.5%; p<0.05). Both treatments were equally effective in reducing BP (14.7±18.0/8.5±8.2 mmHg and 12.7±18.1/7.0±8.3 mmHg) at the 4 year follow-up (p<0.001 vs. baseline; p=n.s. between groups). In 38.6% and 39.7% of patients BP was below 130/80 mmHg (median time-to-target 3 months). There was a significant reduction of cardiovascular morbidity and mortality in favour of ramipril (p=0.033). No significant differences were found for a change in HbA1c as well as for fasting blood glucose levels during follow-up. The rate of adverse events was higher in diuretic treated patients (SAE 15.4 vs. 12.4%; p<0.05; AE 26.6 vs. 25.6%; p=n.s). CONCLUSIONS: Ramipril treatment is preferable over diuretic based treatment regimens for the treatment of hypertension in pre-diabetic patients, because new-onset diabetes is delayed.

Impact of medication adherence on the efficacy of Baroreflex activation therapy.

Therapy adherence significantly determines the success of antihypertensive therapy, especially in patients with resistant hypertension. Our study investigates the impact of drug adherence on the efficacy of Baroreflex-activation-therapy (BAT). In this retrospective analysis, the authors measured blood pressure (BP) and antihypertensive medication adherence (by gas chromatography-mass spectrometry [GC-MS] urine analysis) before and 6 months after BAT initiation. Adherence was defined as detection of ≥80% intake of prescribed medication at the time of follow-up. Response to BAT was defined as BP drop ≥5 mmHg in systolic 24 h-ambulatory BP (ABP) after 6 months. Overall patients (n = 38) median medication adherence was low, but rose from 60% (IQR 25%-100%) to 75% (IQR 38%-100%; p = .0194). After 6 months of BAT, mean systolic and diastolic office BP (-21 ± 25 mmHg and -9 ± 15 mmHg; p < .0001 and .0004) as well as 24 h-ABP dropped significantly (-9 ± 17 mmHg and -5 ± 12 mmHg; p = .0049 and .0280). After 6 months of BAT, 21 patients (60%) could be classified as responders. There was neither significant difference in mean office systolic (-21 ± 23 mmHg vs. -21 ± 28 mmHg; p = .9581) nor in 24 h-systolic ABP decrease (-11 ± 19 mmHg vs. -7 ± 15 mmHg; p = .4450) comparing adherent and non-adherent patients. Whereas Antihypertensive Therapeutic Index (ATI) was unchanged in non-responders, it significantly decreased in responders (from 50 ± 16 to 46 ± 16; p = .0477). These data are the first to show that BAT-initiation leads to a clear BP reduction independently of patients´ medication adherence. Response to BAT is associated with a significant lowering of ATI, which might contribute to an underestimation of BAT efficacy.

Regular Exercise is Associated with a More Favorable Cardiovascular Risk Profile, Better Quality of Life, Less Depression and Less Psychological Stress.

INTRODUCTION: It is well documented that insufficient physical activity (PA) contributes substantially to cardiovascular diseases. The number of physically active people in Germany is still too low. METHODS: In ELITE study in Germany, 4602 participants are regularly examined for cardiovascular risk factors (CVRF). The aim is to motivate participants to improve their CVRF through individual recommendations and regular follow-up. Here, the PA data are presented in correlation with CVRF at baseline. A feature of this presentation is that the usual CVRF but also the effects on psychosocial factors were recorded simultaneously. RESULTS: Participants were divided into 3 groups based on their PA: 1. frequent exercise (FE): daily to 2-3x per week (41.4%), 2. moderate exercise (ME): 1x/week to 2x/month (28.8%), 3. rarely exercise (RE): 1x/month to not at all (29.8%). Age did not differ in the 3 groups. The most common CVRF was arterial hypertension, which decreased significantly with an increase in PA. Diabetes, nicotine, and increased BMI were also significantly less frequent in group 1. Antihypertensives were taken less frequently in this group 1. Less physically active participants were significantly more likely to have 3 or more additional CVRF. While group 1 consumed more fruit (64%) and considerably less pork, in group 2 and 3 only 58.3% and 50.3% respectively included fruit in their diet. FE also had a favorable effect on stress, depression and general well-being, all of which were significantly better in group 1. CONCLUSION: Results confirm the beneficial influences of exercise on known CVRF and on psychosocial parameters. The prevalence of several CVRF per person at low levels of sport is of particular concern, as these participants would benefit most. During a 5-year follow-up, participants will receive intensive education on the need to increase PA. It remains to be seen how successful the effort will be.

Football beats hypertension: results of the 3F (Fit&Fun with Football) study.

OBJECTIVES: Football as the most popular sport could improve insufficient physical activity in patients with cardiovascular risk factors. A modified 'healthy' football training format could motivate hypertensive patients to return to sport and improve risk factors. METHODS: The 3F study: 'Fit and Fun with Football' a prospective interventional study with 1 year follow-up. Football group: n = 103, structured 'health'-football training (1×/week, 90 min) led by Deutscher Fußball Bund-licensed football coaches. Hypertensive patients at least 45 years who have not exercised for several years were compared with a control group (n = 105). PRIMARY STUDY OBJECTIVE: Reduction of office (OBP) and/or 24-h ambulatory blood pressure (BP) monitoring (ABPM) and/or reduction of number or dosage of antihypertensive medication. MAIN RESULTS: OBP values decreased significantly in the football group from 142.6/87.9 to 130.8/81.8 mmHg (P < 0.001), in the control group the values increased slightly (NS). ABPM values decreased significantly in the football group, while a slight increase was found in the control group. At the end of the study, the mean values in the football group of both OPB (P < 0.001) and ABPM (systolic P < 0.001, diastolic P = 0.017) were significantly lower than in the control group. Significantly more people in the football group were able to reduce antihypertensive patients than in the control group (football group:16, control group:6), while more participants in the control group intensified antihypertensive therapy (football group:3, control group:14) (P < 0.001). Among the secondary endpoints, there was a weight loss of 3 kg in the football group and an increase of 1.7 kg in the control group (P < 0.001). CONCLUSION: Offering modified 'healthy' football-training to middle-aged hypertensive patients can lead to better BP control and a reduction of antihypertensive medication. Therefore, the offer of 'health football' should be established and supported by clubs, insurances and authorities.

Influence of cardiovascular risk factors on arterial hypertension and mild cognitive impairment in 4602 participants of the ELITE study.

BACKGROUND: In ELITE (Ernährung, Lebensstil und individuelle Information zur Verhinderung von Herzinfarkt, Schlaganfall und Demenz; german for: Nutrition, Lifestyle and Individual Information for the Prevention of Heart Attack, Stroke and Dementia) data on cardiovascular risk factors, cognitive function and quality of life are prospectively collected, which will be improved through targeted individual information. The aim is to improve the health of the participants and identify the reasons for the lack of implementation. METHODS: Risk factors of 4602 participants were linked to (controlled) hypertension and mild cognitive impairment (MCI). Blood pressure was measured according to the guidelines and the DEMTECT- test was used to detect MCI. RESULTS: The most common risk factor was hypertension (60%). Hypertensive patients were older (56.1 and 44.7 years), had a higher BMI (28 and 24.8 kg/m), frequently physical inactive (26 and 32.4%), diabetes (9.3 and 1.3%), higher LDL (134.7 and 124.1 mg/dl), higher triglycerides (169.6 and 124.8 mg/dl) and lower HDL (57.9 and 65.5 mg/dl) compared with normotensives (P < 0.001). Controlled hypertensive patients are less common men (46.1 and 52.1%, P < 0.001), have a lower BMI (28.3 and 29.1 kg/m, P < 0.001), lower LDL (129.0 and 135.6 mg/dl, P = 0.004) and lower triglycerides (162.5 and 182.3 mg/dl, P = 0.001) compared with treated uncontrolled hypertensive patients. Antihypertensives per person (2.015; 2.017) do not differ. The prevalence of MCI is highly significantly associated with the number of risk factors. in participants without risk factors, the prevalence is 3.9%, in participants with 4 risk factors, 16.3%. In hypertensive patients, the frequency is 11.8% compared with 4.8% for normotensives (P < 0.001). The occurrence of MCI depends significantly from age, blood pressure and diabetes CONCLUSION:: The frequency of MCI is highly significantly associated with the number of cardiovascular risk factors, regardless of age. The prevalence was particularly high among hypertensive patients, which is not often described. The occurrence of MCI depends significantly from age, blood pressure and diabetes. The metabolic syndrome and lack of exercise complicate blood pressure control.

Long-term effects of baroreflex activation therapy: 2-year follow-up data of the BAT Neo system.

OBJECTIVE: Baroreflex activation therapy (BAT) reduces office blood pressure (BP) in patients with resistant hypertension (HTN). Whereas sustained effects from the BAT Rheos device have already been reported, no long-term data on 24-h ambulatory BP (ABP) are currently available for the unilateral BAT Neo device. METHODS: Patients treated with the BAT neo device for resistant hypertension were prospectively included into this observational study. Office and ABP measurements were performed before BAT implantation as well as 6, 12 and 24 months after initiation of BAT. RESULTS: A total of 60 patients with resistant HTN (office BP 172 ± 25/90 ± 17 mmHg, 24-h ABP 150 ± 16/80 ± 12 mmHg, median of antihypertensive drugs 7 (IQR 6-8)) were included. After 24 months, there was a significant reduction of - 25 ± 33/- 9 ± 18 mmHg (n = 50, both p < 0.01) in office BP and - 8 ± 23/- 5 ± 13 mmHg (n = 46, both p = 0.02) in 24-h ABP, while the number of antihypertensive medications was reduced to a median of 5 (4-6) drugs (p < 0.01). Patients with isolated systolic HTN (ISH) experienced a BP-lowering effect in office BP, but not in ABPM at month 24. Using unadjusted BP values, BAT seems to be more effective in combined hypertension (CH) than in ISH. After adjustment for baseline BP values, there was no significant difference in BP reduction between ISH and CH patients. Ambulatory SBP at baseline was the only independent correlate of BP response at month 24. CONCLUSION: BAT reduced office BP and improved relevant parameters of ABP, which is associated with a high cardiovascular risk, in patients with resistant HTN, whereas, after adjustment for baseline BP, BP reduction was not different in patients with CH compared with patients with ISH. However, randomized controlled trials are needed to confirm the effects of BAT on 24-h ABP.

Cost-utility analysis of eprosartan compared to enalapril in primary prevention and nitrendipine in secondary prevention in Europe--the HEALTH model.

OBJECTIVE: To investigate the cost-utility of eprosartan versus enalapril (primary prevention) and versus nitrendipine (secondary prevention) on the basis of head-to-head evidence from randomized controlled trials. METHODS: The HEALTH model (Health Economic Assessment of Life with Teveten for Hypertension) is an object-oriented probabilistic Monte Carlo simulation model. It combines a Framingham-based risk calculation with a systolic blood pressure approach to estimate the relative risk reduction of cardiovascular and cerebrovascular events based on recent meta-analyses. In secondary prevention, an additional risk reduction is modeled for eprosartan according to the results of the MOSES study ("Morbidity and Mortality after Stroke--Eprosartan Compared to Nitrendipine for Secondary Prevention"). Costs and utilities were derived from published estimates considering European country-specific health-care payer perspectives. RESULTS: Comparing eprosartan to enalapril in a primary prevention setting the mean costs per quality adjusted life year (QALY) gained were highest in Germany (Euro 24,036) followed by Belgium (Euro 17,863), the UK (Euro 16,364), Norway (Euro 13,834), Sweden (Euro 11,691) and Spain (Euro 7918). In a secondary prevention setting (eprosartan vs. nitrendipine) the highest costs per QALY gained have been observed in Germany (Euro 9136) followed by the UK (Euro 6008), Norway (Euro 1695), Sweden (Euro 907), Spain (Euro -2054) and Belgium (Euro -5767). CONCLUSIONS: Considering a Euro 30,000 willingness-to-pay threshold per QALY gained, eprosartan is cost-effective as compared to enalapril in primary prevention (patients >or=50 years old and a systolic blood pressure >or=160 mm Hg) and cost-effective as compared to nitrendipine in secondary prevention (all investigated patients).

[Actual Standard of Blood Pressure Measurement - Statement of the German High Blood Pressure League]. / Aktueller Standard der Blutdruckmessung ­ Stellungnahme der Deutschen Hochdruckliga e. V. DHL® ­ Deutsche Gesellschaft für Hypertonie und Prävention.

Arterial hypertension is one of the most prevalent chronic diseases, and a major risk factor for cardiovascular diseases. It is essential to perform the blood pressure measurement under standardized conditions in the office/clinical setting, otherwise inaccuracy of blood pressure values may lead to poor blood pressure control or misdiagnosis. Compliance with these standards by a trained observer is of crucial importance for a reliable and accurate blood pressure measurement in clinical practice. Regardless of the standardized assessment, it has to be kept in mind that available devices on the market may not measure blood pressure accurate enough. Therefore, a validated (e. g. German Hypertension League Quality Seal) blood pressure monitor should be used. Out-of-office (home and ambulatory) blood pressure measurements provide important information beyond determining resting office/clinical BP.

[ELITE study - Nutrition, lifestyle and individual information for the prevention of stroke, dementia and heart attack - Study design and cardiovascular status]. / ELITE-Studie ­ Ernährung, Lebensstil und individuelle Information zur Verhinderung von Schlaganfall, Demenz und Herzinfarkt ­ Studiendesign und kardiovaskuläre Aufnahmedate.

BACKGROUND: For the prevention of cardiovascular risk factors (RF) there are numerous recommendations of professional societies, which relate to the personal way of life of individuals (for example nutrition/diet, physical activity, stress reduction etc.). The implementation of these recommendations is so far poor. In the ELITE study, data on RF, nutritional behavior, physical activity and quality of life in the Oldenburger Münsterland region are to be collected prospectively and improved by individual information. Reasons for the lack of implementation of preventive measures should be recognized. METHODS: The study is conducted as an interventional cohort study (DRKS-No.: 00 006 813, Ethics vote University of Göttingen). Up to 5000 people (with or without pre-existing RF) are aimed to be included. All participants receive a computer-generated report of their personal risk profile with detailed recommendations based on current guidelines. In addition, it is recommended to visit the family doctor to discuss the findings and, if necessary, initiate diagnostic or therapeutic measures. Every year, follow-up examinations take place for up to 5 years. RESULTS: By 31.12.2017 4602 participants (mean age 51.5 (±â€Š15.7) years, 53.7 % female) were admitted. Overweight were 39 % of the participants, obese 20.4 %. Most frequent anamnestic RF is hypertension (31.4 %), mean blood pressure was 138.4 ±â€Š16.6/83.0 ±â€Š9.9 mmHg. 2165 (47.0 %) participants show hypertensive blood pressure values. The second most frequent anamnestic RF are lipid metabolism disorders (16.6 %). CONCLUSION: The incidence of participants with at least one cardiovascular RF is very high (49.5 %, 16.6 % multiple RF). The incidence of RF is similar to other epidemiological data in Germany, so the ELITE collective allows a good comparison with other surveys.

Effect of baroreflex activation therapy on renal sodium excretion in patients with resistant hypertension.

OBJECTIVE: Activation of the sympathetic nervous system increases sodium retention in resistant hypertension. Baroreflex activation therapy (BAT) is an interventional method to reduce sympathetic overactivity in patients with resistant hypertension. This study aimed to assess the effect of BAT on urinary sodium excretion. METHODS: From 2012 to 2015, consecutive patients with resistant hypertension and blood pressure (BP) above target despite polypharmacy strategies were consecutively included in this observational study. BAT was provided with the individual adaption of programmed parameters over the first months. 24-h urinary sodium excretion (UNa) was estimated at baseline and after 6 months using the Kawasaki formula in patients undergoing BAT. Additionally, the fractional sodium excretion, plasma renin activity, and aldosterone levels were assessed. RESULTS: Forty-two patients completed the 6-month follow-up period. Office systolic and ambulatory 24-h systolic BP at baseline were 169 ± 27 mmHg and 148 ± 16 mmHg despite a median intake of 7(3-9) antihypertensive drugs. After 6 months of BAT, systolic office BP decreased to 150 ± 29 mmHg (p < 0.01), 24-h systolic BP to 142 ± 22 mmHg (p = 0.04) and 24-h UNa increased by 37% compared to baseline (128 ± 66 vs. 155 ± 83 mmol/day, p < 0.01). These findings were accompanied by a significant increase in fractional sodium excretion (0.74% [0.43-1.47] to 0.92% [0.61-1.92]; p = 0.02). However, in contrast to the significant BP reduction, eGFR, plasma sodium, renin activity and aldosterone levels did not change during BAT. The increase in sodium excretion was correlated with the change in eGFR (r = 0.371; p = 0.015). CONCLUSION: The present study revealed a significant increase of estimated 24-h UNa which may contribute to the long-term BP-lowering effects of this interventional method.

The PHARAO study: prevention of hypertension with the angiotensin-converting enzyme inhibitor ramipril in patients with high-normal blood pressure: a prospective, randomized, controlled prevention trial of the German Hypertension League.

BACKGROUND: The prevention of hypertension with the angiotensin-converting enzyme inhibitor ramipril in patients with high-normal blood pressure study addresses the issue of whether progression to manifest hypertension in patients with high-normal blood pressure can be prevented with treatment. METHODS: A total of 1008 participants with high-normal office blood pressure were randomized to ramipril treatment group (n = 505) and a control group (n = 503). The patients were followed up for 3 years. Primary endpoint was to prevent or delay the progression to manifest hypertension. Secondary endpoints were reduction in the incidence of cerebrovascular and cardiovascular events, as well as the development of hypertension as defined by ambulatory blood pressure monitoring. FINDINGS: One hundred and fifty-five patients (30.7%) in the ramipril group, and 216 (42.9%) in the control group reached the primary endpoint (relative risk reduction 34.4%, P = 0.0001). Ramipril also proved to be more effective in reducing the incidence of manifest office hypertension in patients with baseline ambulatory blood pressure monitoring high-normal blood pressure. The incidence of cerebrovascular and cardiovascular events showed no statistically significant differences between the two groups. Cough was more frequent in the ramipril group (4.8 vs. 0.4%). INTERPRETATION: There is now good clinical evidence that patients with high-normal blood pressure (prehypertension) are more likely to progress to manifest hypertension than patients with optimal or normal blood pressure. Additional ambulatory blood pressure monitoring seems to be essential to achieve correct diagnosis. Treatment of patients with high-normal office blood pressure with the angiotensin-converting enzyme inhibitor was well tolerated, and significantly reduced the risk of progression to manifest hypertension.

First-line antihypertensive treatment in patients with pre-diabetes: rationale, design and baseline results of the ADaPT investigation.

BACKGROUND: Recent clinical trials reported conflicting results on the reduction of new-onset diabetes using RAS blocking agents. Therefore the role of these agents in preventing diabetes is still not well defined. Ramipril is an ACE inhibitor (ACEi), that has been shown to reduce cardiovascular events in high risk patients and post-hoc analyses of the HOPE trial have provided evidence for its beneficial action in the prevention of diabetes. METHODS: The ADaPT investigation ("ACE inhibitor-based versus diuretic-based antihypertensive primary treatment in patients with pre-diabetes") is a 4-year open, prospective, parallel group phase IV study. It compares an antihypertensive treatment regimen based on ramipril versus a treatment based on diuretics or betablockers. The primary evaluation criterion is the first manifestation of type 2 diabetes. The study is conducted in primary care to allow the broadest possible application of its results. The present article provides an outline of the rationale, the design and baseline characteristics of AdaPT and compares these to previous studies including ASCOT-BLPA, VALUE and DREAM. RESULTS: Until March 2006 a total of 2,015 patients in 150 general practices (general physicians and internists) throughout Germany were enrolled. The average age of patients enrolled was 67.1 +/- 10.3 years, with 47% being male and a BMI of 29.9 +/- 5.0 kg/m2. Dyslipidemia was present in 56.5%. 37.8% reported a family history of diabetes, 57.8% were previously diagnosed with hypertension (usually long standing). The HbA1c value at baseline was 5.6 %. Compared to the DREAM study patients were older, had more frequently hypertension and patients with cardiovascular disease were not excluded. CONCLUSION: Comparing the ADaPT design and baseline data to previous randomized controlled trial it can be acknowledged that AdaPT included patients with a high risk for diabetes development. Results are expected to be available in 2010. Data will be highly valuable for clinical practice due to the observational study design.

[Effects of long-term antihypertensive therapy with losartan on blood pressure and cognitive function in patients with essential hypertension and other cerebrovascular risk factors (AWARE observational study)]. / Effekte der antihypertensiven Langzeittherapie mit Losartan auf den Blutdruck und die kognitive Funktion bei Patienten mit essentieller Hypertonie und weiteren zerebrovaskulären Risikofaktoren (AWARE-Beobachtungsstudie).

BACKGROUND AND PURPOSE: As arterial hypertension is the most important risk factor for ischemic stroke, the relevant guidelines recommend rigorous treatment to normalize blood pressure. Hypertension can also be associated with cognitive decline and dementia. Therefore, the effect of a long-term therapy with the AT(1) antagonist losartan (+/- hydro chloro thiazide [HCTZ]) on cognitive function in patients with essential hypertension and additional cerebrovascular risk factors was investigated. PATIENTS AND METHODS: Prospective, open observational study in 6,206 adult patients with known essential hypertension and cerebrovascular risk factors (most with a 10-year stroke risk of >or= 20% based on the Framingham Score). Demographic data, blood pressure, selected laboratory parameters, and cognitive function (c.I. test) were determined at baseline and after 3, 6, and 12 months. RESULTS: The patients' mean age was 65.8+/-10.7 years and 46.1% of the patients were male. In addition to treatment with losartan +/- HCTZ, 54.1% of the patients received one or more additional antihypertensive agents. After 1 year of treatment, systolic/diastolic blood pressure fell from its baseline level of 158.1/90.3 mmHg to 137.3/80.6 mmHg (-20.8/-9.7 mmHg). The proportion of patients with no/mild/severe cognitive impairment was 30.0%/30.3%/39.7% at baseline and 34.8%/28.1%/37.1% at the end of the study. In patients with cognitive impairment, fibrinogen and hsCRP (high-sensitive C-reactive protein) levels were significantly elevated. Adverse events (AEs) were reported in 231 patients (3.7%), while serious/nonserious AEs possibly related to the study medication were reported in only six (0.1%) and 38 patients (0.6%), respectively. CONCLUSION: A high proportion of patients with hypertension shows cognitive impairment; therefore, use of appropriate tests to detect this should be considered. The losartan-based antihypertensive treatment increased the proportion of patients with normal cognitive function, reduced blood pressure, and was well tolerated in the primary-care setting.