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1.
Am J Cardiol ; 2021 Feb 19.
Artigo em Inglês | MEDLINE | ID: mdl-33617811

RESUMO

Prompt treatment may mitigate the adverse effects of congestion in the early phase of heart failure (HF) hospitalization, which may lead to improved outcomes. We analyzed 814 acute HF patients for the relationships between time to first intravenous loop diuretics, changes in biomarkers of congestion and multi-organ dysfunction, and 1-year composite endpoint of death or HF hospitalization. B-type natriuretic peptide (BNP), high sensitivity cardiac troponin I (hscTnI), urine and serum neutrophil gelatinase-associated lipocalin (NGAL), and galectin 3 were measured at hospital admission, hospital day 1, 2, 3 and discharge. Time to diuretics was not correlated with the timing of decongestion defined as BNP decrease ≥ 30% compared to admission. Earlier BNP decreases but not time to diuretics were associated with earlier and greater decreases in hscTnI and urine NGAL, and lower incidence of the composite endpoint. After adjustment for confounders, only no BNP decrease at discharge was significantly associated with mortality but not the composite endpoint (p = 0.006 and p = 0.062, respectively). In conclusion, earlier time to decongestion but not the time to diuretics was associated with better biomarker trajectories. Residual congestion at discharge rather than the timing of decongestion predicted a worse prognosis.

2.
Artigo em Inglês | MEDLINE | ID: mdl-33508124

RESUMO

BACKGROUND: Hyperkalemia is a common condition in patients with comorbidities such as chronic kidney disease (CKD) or congestive heart failure. Moreover, severe hyperkalemia is a potentially life-threatening condition that is associated with a higher risk of adverse clinical events such as ventricular arrhythmias and sudden cardiac death. Currently, data regarding the prognostic implications of chronic hyperkalemia are available; however, the information about the long-term clinical consequences after an episode of severe hyperkalemia remains scarce. The objective of the study was to evaluate the association between the trajectory of potassium measurements in patients with acute hyperkalemia and long-term all-cause mortality. METHODS: This is a retrospective observational study that included patients with acute severe hyperkalemia (K > 6 mEq/L) without hemolysis in the emergency room of Dr. Peset University Hospital in Valencia, Spain searching the lab database from January 2016 to March 2017. The multivariable-adjusted association of serum potassium with mortality was assessed by using comprehensive state-of-the-art regression methods that can accommodate time-dependent exposure modelling. RESULTS: We found 172 episodes of acute hyperkalemia in 160 patients in the emergency room. The mean age of the sample was 77 ± 12 years and 60.5% were males. The most frequent comorbidities were CKD (71.2%), heart failure (35%) and diabetes mellitus (56.9%). Only 11.9% of the patients were on chronic dialysis. A quarter of the patients did not have previous CKD making hyperkalemia as an unpredictable life-threatening complication. During the acute episode, mean potassium and eGFR were 6.6 ± 0.6 (range: 6,1-9,2), and eGFR: 23 ± 16 (r : 2-84). After a median follow-up of 17.3 (IQR: 2.2-23.7) months, 68 patients died (42.5%). Recurrences of hyperkalemia (K > 5.5 mEq/L) were detected in 39.5%% of the patients who were monitored during follow-up. We found that previous potassium levels during an acute severe hyperkalemia episode were not predictors of mortality. Conversely, the post-discharge longitudinal trajectories of potassium were able to predict all-cause mortality (overall p-value = 0.0015). The effect of transitioning from hyperkalemia to normokalaemia (K > 5.5 to K ≤ 5.5 after the acute episode was significant and inversely associated with the risk of mortality. CONCLUSION: The potassium levels prior to a severe hyperkalemic event do not predict mortality. Conversely, following an episode of acute severe hyperkalemia, serial kinetic of potassium trajectories predicts the risk of death. Further evidence is needed to confirm these findings and clarify the optimal long-term management of these patients.

3.
Sci Rep ; 11(1): 732, 2021 Jan 12.
Artigo em Inglês | MEDLINE | ID: mdl-33436787

RESUMO

To assess mortality trends at 1 and 3 years from 2001 to 2018 in a real-life cohort of HF outpatients from different etiologies with depressed and preserved LVEF. A total of 2368 consecutive patients with HF (mean age 66.4 ± 12.9 years, 71% men, 15.4% with preserved LVEF) admitted to a HF clinic from August 2001 to September 2018 were included in the study. Patients were divided into five quintiles (Q) according to the period of admission. Trends for all-cause and cardiovascular mortality from Q1 to Q5 were assessed by linear regression. Patients with LVEF < 50% had a progressive decrease in the rates of all-cause and cardiovascular death at 1 year (12.1% in Q1 to 6.5% in Q5, p = 0.003; and 8.4% in Q1 to 3.8% in Q5, p = 0.007, respectively) and 3 years (30.5% in Q1 to 17.0% in Q5, p = 0.003; and 23.9% in Q1 to 9.8% in Q5, p = 0.003, respectively). These trends remained significant after adjusting for clinical characteristics and risk. No significant trend in mortality was observed in patients with LVEF ≥ 50%. In a cohort of real-life ambulatory patients with HF, mortality progressively declined in patients with LVEF < 50%, but the same trend was not observed in patients with preserved LVEF.

4.
Surg Endosc ; 35(3): 1476-1481, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33398568

RESUMO

BACKGROUND: While inflow control can be easily applied by Pringle maneuver, outflow control of the left liver has not been formally described. We report here a safe and reproductible technique of middle and left hepatic veinous trunk control (MLHVC) before parenchymal transection during laparoscopic left hepatectomy. METHODS: A retrospective review of laparoscopic liver resection was conducted from January 2013 to March 2018 from our prospective database. All cases of laparoscopic left hepatectomy (LLH) were included, and intra- and postoperative outcomes data collected. We collected cases where the middle and left hepatic vein trunk control has been attempted and clamping used, and we analyzed outcomes associated with this maneuver. RESULTS: MLHVC was attempted in 28 cases (77.8) of the 36 LLH identify in a monocentric study. It was technically not feasible only in 3 cases (8.3%) and clamping applied in 15 cases (41.7%). No significant intraoperative unexpected event occurred. CONCLUSION: We present here a technique for left liver outflow control that can be safely added to the armamentarium of laparoscopic liver surgery.

5.
Circ Cardiovasc Imaging ; 13(12): e011491, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33297764

RESUMO

Background Cardiac magnetic resonance (CMR) permits robust risk stratification of discharged ST-segment-elevation myocardial infarction patients, but its indiscriminate use in all cases is not feasible. We evaluated the utility of left ventricular ejection fraction (LVEF) by echocardiography for a selective use of CMR after ST-segment-elevation myocardial infarction. Methods Echocardiography and CMR were performed in 1119 patients discharged for ST-segment-elevation myocardial infarction included in a multicenter registry. The prognostic power of CMR beyond echocardiography-LVEF was assessed using adjusted C statistic, net reclassification improvement index, and integrated discrimination improvement index. Results During a 4.8-year median follow-up, 136 (12%) first major adverse cardiac events (MACE) occurred (47 cardiovascular deaths and 89 readmissions for acute heart failure). In the entire group, CMR-LVEF (but not echocardiography-LVEF) independently predicted MACE occurrence. The MACE rate significantly increased only in patients with CMR-LVEF<40% (≥50%: 7%, 40%-49%: 9%, <40%: 27%, P<0.001). Most patients displayed echocardiography-LVEF≥50% (629, 56%), and they had a low MACE rate (57/629, 9%). In patients with echocardiography-LVEF<50% (n=490, 44%), the MACE rate was also low in those with CMR-LVEF≥40% (24/278, 9%) but significantly increased in patients with CMR-LVEF<40% (55/212, 26%; P<0.001). Compared with echocardiography-LVEF, CMR-LVEF significantly improved MACE prediction in the group of patients with echocardiography-LVEF<50% (C statistic, 0.80 versus 0.72; net reclassification improvement index, 0.73; integrated discrimination improvement index, 0.10) but not in those with echocardiography-LVEF≥50% (C statistic 0.66 versus 0.66; net reclassification improvement index, 0.17; integrated discrimination improvement index, 0.01). Conclusions A straightforward strategy based on a selective use of CMR for risk prediction in ST-segment-elevation myocardial infarction patients with echocardiography-LVEF<50% can provide insights into patient care. The cost-effectiveness of this approach, as well as the direct implications in clinical management, should be further explored.

6.
J Card Fail ; 2020 Dec 06.
Artigo em Inglês | MEDLINE | ID: mdl-33296713

RESUMO

BACKGROUND: Multiple different pathophysiologic processes can contribute to worsening renal function (WRF) in acute heart failure (AHF). METHODS AND RESULTS: We retrospectively analyzed 787 AHF patients for the relationship between changes in serum creatinine and biomarkers including brain natriuretic peptide (BNP), high sensitivity cardiac troponin I (hscTnI), galectin 3, serum neutrophil gelatinase-associated lipocalin (NGAL) and urine NGAL. WRF was defined as an increase of ≥ 0.3 mg/dl or 50% in creatinine within first 5 days of hospitalization. WRF was observed in 25% of patients. Changes in biomarkers and creatinine were poorly correlated (r ≤ 0.21) and no biomarker predicted WRF better than creatinine. In the multivariable Cox analysis, BNP and hscTnI, but not WRF, were significantly associated with the one-year composite of death or HF hospitalization. WRF with an increasing urine NGAL predicted an increased risk of HF hospitalization. CONCLUSIONS: Biomarkers were not able to predict WRF better than creatinine. One-year outcomes were associated with biomarkers of cardiac stress and injury but not with WRF, while a kidney injury biomarker may prognosticate WRF for HF hospitalization.

7.
Eur J Heart Fail ; 2020 Dec 19.
Artigo em Inglês | MEDLINE | ID: mdl-33340221

RESUMO

AIMS: This retrospective analysis sought to identify markers that might distinguish between acute heart failure (HF) and worsening HF in chronic outpatients. METHODS AND RESULTS: The BIOSTAT-CHF index cohort included 2516 patients with new or worsening HF symptoms: 1694 enrolled as inpatients (acute HF) and 822 as outpatients (worsening HF in chronic outpatients). A validation cohort included 935 inpatients and 803 outpatients. Multivariable models were developed in the index cohort using clinical characteristics, routine laboratory values, and proteomics data to examine which factors predict adverse outcomes in both conditions and to determine which factors differ between acute HF and worsening HF in chronic outpatients, validated in the validation cohort. Patients with acute HF had substantially higher morbidity and mortality (6-month mortality was 12.3% for acute HF and 4.7% for worsening HF in chronic outpatients). Multivariable models predicting 180-day mortality and 180-day HF readmission differed substantially between acute HF and worsening HF in chronic outpatients. Carbohydrate antigen 125 was the strongest single biomarker to distinguish acute HF from worsening HF in chronic outpatients, but only yielded a C-index of 0.71. A model including multiple biomarkers and clinical variables achieved a high degree of discrimination with a C-index of 0.913 in the index cohort and 0.901 in the validation cohort. CONCLUSIONS: This study identifies different characteristics and predictors of outcome in acute HF patients as compared to outpatients with chronic HF developing worsening HF. The markers identified may be useful in better diagnosing acute HF and may become targets for treatment development.

8.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-33349589

RESUMO

INTRODUCTION AND OBJECTIVES: Discordant data have been reported on the prognosis of myocardial infarction with nonobstructive coronary arteries (MINOCA). Moreover, few data are available on the impact of angiographic subtypes. The objectives of this study were to assess the prognostic impact on the long-term follow-up of the diagnosis of MINOCA and its angiographic subtypes. METHODS: We included 591 consecutive patients with non-ST-segment elevation myocardial infarction (NSTEMI) who underwent coronary angiography. MINOCA was classified according to angiographic findings as smooth coronary arteries, mild irregularities (< 30% stenosis), and moderate atherosclerosis (30%-49% stenosis). The primary endpoint was a composite of mortality, nonfatal myocardial infarction, and revascularization (MACE) at a median of 5 years of follow-up. RESULTS: A total of 121 patients (20.5%) showed no obstructive lesions. MINOCA was associated with a lower occurrence of MACE (P=.014; HR, 0.63; 95%CI, 0.44-0.91) and was confirmed as an independent factor in the multivariate analysis (P=.018; HR, 0.63; 95%CI, 0.43-0.92). On analysis of the separate components of the main endpoint, MINOCA was significantly associated with a lower rate of myocardial infarction and revascularization, but not with mortality. Analysis of angiographic subtypes among MINOCA patients showed that smooth coronary arteries were a statistically significant protective factor on both univariate and multivariate analysis, while mild irregularities and 30% to 49% plaques were associated with a higher risk of MACE. CONCLUSIONS: MINOCA is associated with a lower rate of MACE, driven by fewer reinfarctions and revascularizations. Within the angiographic subtypes of MINOCA, smooth arteries were independently associated with a lower number of MACE.

10.
Cardiol J ; 2020 Dec 21.
Artigo em Inglês | MEDLINE | ID: mdl-33346372

RESUMO

BACKGROUND: There are no well-established predictors of recurrent ischemic coronary events after an acute coronary syndrome (ACS). Higher levels of homocysteine have been reported to be associated with an increased atherosclerotic burden. The primary endpoint was to assess the relationship between homocysteine at discharge and very long-term recurrent myocardial infarction (MI). METHODS: 1306 consecutive patients with ACS were evaluated (862 with non-ST-segment elevation ACS [NSTEACS] and 444 with ST-segment elevation myocardial infarction [STEMI]) discharged from October 2000 to June 2003 in a single teaching-center. The relationship between homocysteine at discharge and recurrent MI was evaluated through bivariate negative binomial regression accounting for mortality as a competitive event. RESULTS: The mean age was 66.8 ± 12.4 years, 69.1% were men, and 32.2% showed prior diabetes mellitus. Most of the patients were admitted for an NSTEACS (66.0%). The median (interquartile range) GRACE risk score, Charlson comorbidity index, and homocysteine were 144 (122-175) points, 1 (1-2) points, and 11.9 (9.3-15.6) µmol/L, respectively. In-hospital revascularization was performed in 26.3% of patients. At a median follow-up of 9.7 (4.5-15.1) years, 709 (54.3%) deaths were registered and 779 recurrent MI in 478 (36.6%) patients. The rates of recurrent MI were higher in patients in the upper homocysteine quartiles (p < 0.001). After a multivariate adjustment, homocysteine along its continuum remained almost linearly associated with a higher risk of recurrent MI (p = 0.001) and all-cause mortality (p < 0.001). CONCLUSIONS: In patients with ACS, higher homocysteine levels identified those at a higher risk of recurrent MI at very long-term follow-up.

11.
Am J Med ; 2020 Oct 24.
Artigo em Inglês | MEDLINE | ID: mdl-33228950

RESUMO

BACKGROUND: Older adult patients with frailty are rarely involved in rehabilitation programs after myocardial infarction. Our aim was to investigate the benefits of exercise intervention in these patients. METHODS: A total of 150 survivors after acute myocardial infarction, ≥70 years and with pre-frailty or frailty (Fried scale ≥1 points), were randomized to control (n = 77) or intervention (n = 73) groups. The intervention consisted of a 3-month exercise program, under physiotherapist supervision, followed by an independent home-based program. The main outcome was frailty (Fried scale) at 3 months and 1 year. Secondary endpoints were clinical events (mortality or any readmission) at 1 year. RESULTS: Mean age was 80 years (range = 70-96). In the intervention group, 44 (60%) out of 73 patients participated in the program and 23 (32%) completed it. Overall, there was a decrease in the Fried score in the intervention group at 3 months, with no effect at 1 year. However, in the intention-to-treat analysis, such change did not achieve statistical significance (P = 0.110). Only treatment comparisons made among the subgroups that participated in (P = 0.033) and completed (P = 0.018) the program achieved statistical significance. There were no differences in clinical events. Worse Fried score trajectory along follow-up increased mortality risk (hazard ratio [HR] = 2.38, 95% confidence interval [CI] 1.24-4.55, P = 0.009) CONCLUSIONS: Recruitment and retention for a physical program in older adult patients with frailty after myocardial infarction was challenging. Frailty status improved in the subgroup that participated in the program, although this benefit was attenuated after shifting to a home-based program. A better frailty trajectory might influence midterm prognosis. (ClinicalTrials.govNCT02715453).

12.
J Card Fail ; 2020 Oct 08.
Artigo em Inglês | MEDLINE | ID: mdl-33038531

RESUMO

BACKGROUND: Identifying patients at risk of poor diuretic response in acute heart failure (AHF) is critical to make prompt adjustments in therapy. The objective of this study was to investigate whether the circulating levels of soluble ST2 predict the cumulative diuretic efficiency (DE) at 24 and 72 hours in patients with AHF and concomitant renal dysfunction. METHODS AND RESULTS: This is a post hoc analysis of the IMPROVE-HF trial, in which we enrolled 160 patients with AHF and renal dysfunction (estimated glomerular filtrate rate of <60 mL/min/1.73 m2). DE was calculated as the net fluid output produced per 40 mg of furosemide equivalents. The association between sST2 and DE was evaluated by using multivariate linear regression analysis. The median cumulative DE at 24 and 72 hour was 747 mL (interquartile range 490-1167 mL) and 1844 mL (interquartile range 1142-2625 mL), respectively. The median sST2 and mean estimated glomerular filtrate rate were 72 ng/mL (interquartile range 47-117 ng/mL), and 34.0 ± 8.5 mL/min/1.73 m2, respectively. In a multivariable setting, higher sST2 were significant and nonlinearly related to lower DE both at 24 and 72 hours (P = .002 and P = .019, respectively). CONCLUSIONS: In patients with AHF and renal dysfunction at presentation, circulating levels of sST2 were independently and negatively associated with a poor diuretic response, both at 24 and 72 hours.

13.
ESC Heart Fail ; 2020 Oct 11.
Artigo em Inglês | MEDLINE | ID: mdl-33040491

RESUMO

AIMS: The mechanisms underlying the beneficial effect of ferric carboxymaltose (FCM) in patients with heart failure (HF) and iron deficiency (ID) have not been completely characterized. The Myocardial-IRON trial was a double-blind, randomized trial that evaluated myocardial iron repletion following FCM vs. placebo in 53 patients with HF and ID. In this post hoc analysis, we evaluated whether treatment with FCM was associated with cardiac magnetic resonance changes in left and right ventricular function (LVEF and RVEF, respectively) at different points of systolic dysfunction. METHODS AND RESULTS: We included patients from the Myocardial-IRON trial with left and right ventricular systolic dysfunction (LVSD and RVSD, respectively) at enrolment. Linear mixed regression models were used to evaluate changes at 7 and 30 days on LVEF and RVEF at cardiac magnetic resonance. At enrolment, 27 (50.9%) and 38 (71.7%) patients had LVEF < 40% (LVSD1 ) or <45% (LVSD2 ), respectively, and 10 (18.9%) and 17 (32.1%) patients had RVEF < 45% (RVSD1 ) or <51% in women and <52% in men (RVSD2) , respectively. Treatment with FCM was associated with a significant improvement in LVEF at 30 days (LVSD1 : Δ2.3%, P < 0.001; LVSD2 : Δ4.1, P = 0.014). FCM was also associated with a significant and early improvement in RVEF at 7 days (RVSD1 : Δ6.9%, P = 0.003; RVSD2 : Δ3.2%, P = 0.003) that persisted at 30 days (RVSD1 : Δ8.1%, P < 0.001; RVSD2 : Δ4.7%, P < 0.001). CONCLUSIONS: In patients with HF and systolic dysfunction with ID, FCM was associated with short-term improvement in LVEF and, especially, in RVEF.

15.
Scand Cardiovasc J ; : 1-6, 2020 Oct 08.
Artigo em Inglês | MEDLINE | ID: mdl-33030056

RESUMO

OBJECTIVES: Serum levels of matrix metalloproteinase-12 cleaved fragment of titin (TIM), a novel circulatory biomarker specific for cardiac titin degradation, has emerged as a potential biomarker in cardiovascular diseases. In this work, we aimed to evaluate the association between TIM and maximal functional capacity assessed by the percentage of predicted peak exercise oxygen uptake (pp-peakVO2) in patients with heart failure and preserved ejection fraction (HFpEF). Design. In this post-hoc study, we included 46 stable symptomatic (New York Heart Association II-III) HFpEF patients enrolled in the TRAINING-HF study (NCT02638961). pp-peak-VO2 was calculated from baseline values. Baseline circulating levels of TIM were measured by competitive ELISA in serum from the TRAINING-HF patients. The independent association between TIM and pp-peakVO2 was evaluated by multivariate linear regression analysis. Results. The mean age of the sample was 73.8 ± 8.7 years, 56.5% were females, and 76.1% were on NYHA II. The medians of pp-peakVO2 and TIM were 60.9% (50.4-69.3), and 130.1 ng/mL (98.1-159.5), respectively. The median of NT-proBNP was 912 pg/mL (302-1826). pp-peakVO2 was significant and inversely correlated with TIM (r= -41, p = .005). In multivariate analysis, after adjusting for NYHA class, hypertension, body mass index, and glomerular filtration rate, higher TIM was significantly associated with lower pp-peak VO2 (p = .029). Conclusions. In this sample of stable and symptomatic HFpEF patients, higher serum levels of TIM identified patients with worse functional status.

16.
Atherosclerosis ; 313: 76-80, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-33032236

RESUMO

BACKGROUND AND AIMS: The ORION 10-11 trials have reported the efficacy of Inclisiran on low-density lipoprotein cholesterol (LDLc) reduction, and also suggested prevention of major cardiovascular events (MACE) incidence. METHODS: We have performed a meta-analysis of the available studies, involving PCSK9 inhibitors or Inclisiran for >6 months, that reported the incidence of MACE. The primary endpoint was MACE incidence, as reported in outcomes-based randomized clinical trials (OB-RCT) and non OB-RCT. Analyses were performed using fixed effect models and fractional polynomial regression. RESULTS: The meta-analysis included a total of 57,431 patients, 1592 treated with Inclisiran and 28,259 with PSCK9 inhibitors (17,244 with evolocumab and 11,015 with alirocumab). Baseline mean LDLc was 104.1 (12.9) mg globally. On-treatment mean LDLc was 40.1 (7.8) mg/dl and mean absolute LDLc reduction was 60.6 (10.3) mg/dl. A total of 5389 MACE were reported, 2482 in patients receiving the study drug and 2907 in patients assigned to placebo. Treatment was associated with OB-RCT and no heterogeneity was observed. The estimation of MACE reduction associated with LDLc reduction, adjusted by age, diabetes, hypertension and baseline LDLc, provided a linear trend in the risk of MACE and LDLc reduction that was linear and all studies fitted properly. CONCLUSIONS: The results of the ORION 10-11 trials are in concordance with results of trials involving treatment with PCSK9 inhibitors. The results of the ORION-4 trial will provide definite evidence on the effects of Inclisiran on MACE reduction.

18.
ESC Heart Fail ; 2020 Sep 22.
Artigo em Inglês | MEDLINE | ID: mdl-32964683

RESUMO

AIMS: The aim of this study was to evaluate the safety profile in terms of changes in renal function after co-treatment with sacubitril/valsartan and empagliflozin in patients with type 2 diabetes (T2D) and heart failure with reduced ejection fraction (HFrEF). METHODS AND RESULTS: This multicentre observational analysis included 108 patients with T2D and HFrEF treated with both agents: baseline sacubitril/valsartan (Group A; n = 43), baseline empagliflozin (Group B; n = 42), or both agents initiated simultaneously (Group C; n = 23). The primary endpoint was estimated glomerular filtration rate (eGFR) dynamics across treatment groups. A binary characterization of worsening renal function (WRF)/improved renal function (IRF) was included in the primary endpoint. WRF and IRF were defined as an increase/decrease in serum creatinine ≥ 0.3 mg/dL or GFR ≥ 20%. Changes in quantitative variables were evaluated using joint modelling of survival and longitudinal data (JM). Rates and their treatment differences were determined by Poisson regression. The mean left ventricle ejection fraction and eGFR were 32 ± 6% and 70 ± 28 mL/min/1.73 m2 , respectively. At a median follow-up of 1.01 years (inter-quartile range 0.71-1.50), 377 outpatient visits were recorded. Although there were differences in GFR trajectories over time within each treatment, they did not achieve statistical significance (omnibus P = 0.154). However, when these differences were contrasted among groups, there was a significant decrease in GFR in Group A as compared with Group B (P = 0.002). The contrast between Groups C and B was not significant (P = 0.430). These differences were also reflected when the rates for WRF and IRF were contrasted among treatments. CONCLUSIONS: The co-administration of sacubitril/valsartan and empagliflozin in patients with HFrEF and concomitant T2D appears to be safe in terms of renal function.

20.
ESC Heart Fail ; 2020 Sep 17.
Artigo em Inglês | MEDLINE | ID: mdl-32940428

RESUMO

AIMS: The role of non-invasive telemedicine (TM) combining telemonitoring and teleintervention by videoconference (VC) in patients recently admitted due to heart failure (HF) ('vulnerable phase' HF patients) is not well established. The aim of the Heart failure Events reduction with Remote Monitoring and eHealth Support (HERMeS) trial is to assess the impact on clinical outcomes of implementing a TM service based on mobile health (mHealth), which includes remote daily monitoring of biometric data and symptom reporting (telemonitoring) combined with VC structured, nurse-based follow-up (teleintervention). The results will be compared with those of the comprehensive HF usual care (UC) strategy based on face-to-face on-site visits at the vulnerable post-discharge phase. METHODS AND RESULTS: We designed a 24 week nationwide, multicentre, randomized, controlled, open-label, blinded endpoint adjudication trial to assess the effect on cardiovascular (CV) mortality and non-fatal HF events of a TM-based comprehensive management programme, based on mHealth, for patients with chronic HF. Approximately 508 patients with a recent hospital admission due to HF decompensation will be randomized (1:1) to either structured follow-up based on face-to-face appointments (UC group) or the delivery of health care using TM. The primary outcome will be a composite of death from CV causes or non-fatal HF events (first and recurrent) at the end of a 6 month follow-up period. Key secondary endpoints will include components of the primary event analysis, recurrent event analysis, and patient-reported outcomes. CONCLUSIONS: The HERMeS trial will assess the efficacy of a TM-based follow-up strategy for real-world 'vulnerable phase' HF patients combining telemonitoring and teleintervention.

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