Short-Term Water- and Land-Based Exercise Training Comparably Improve Exercise Capacity and Vascular Function in Patients After a Recent Coronary Event: A Pilot Randomized Controlled Trial.

BACKGROUND: We hypothesized that a 2-week twice daily aquatic endurance plus calisthenics exercise training program: (i) increases aerobic exercise capacity (peak oxygen uptake/ V ˙ O2peak), (ii) improves endothelium-dependent flow-mediated vasodilation (FMD), and (iii) reduces circulating markers of low-grade inflammation and hemostasis, as compared to land-based endurance plus calisthenics exercise training or no exercise in patients undergoing short-term residential cardiac rehabilitation after a recent coronary artery disease (CAD) event. METHODS: Patients with a recent myocardial infarction or revascularization procedure were randomized into two interventional groups and a control group. The interventional groups underwent supervised aerobic endurance plus calisthenics exercise training either in thermo-neutral water or on land at moderate intensity (60-80% of the peak heart rate achieved during symptom-limited graded exercise testing) for 30 min twice daily for 2 weeks (i.e., 24 sessions). The control group was deferred from supervised exercise training for the 2-week duration of the intervention, but was advised low-to-moderate intensity physical activity at home while waiting. At baseline and after the intervention period, all participants underwent estimation of aerobic exercise capacity, brachial artery flow-mediated dilatation (FMD, measured ultrasonographically at rest and during reactive hyperemia after 4.5 min of forearm cuff inflation), markers of cardiac dysfunction (NT-proBNP), inflammation (hsCRP, IL-6, IL-8, IL-10), cell adhesion (ICAM, P-selectin), and hemostasis (fibrinogen, D-dimer). RESULTS: A total of 89 patients (mean age 59.9 ± 8.2 years, 77.5% males, V ˙ O2peak at baseline 14.8 ± 3.5 ml kg-1 min-1) completed the study. Both exercise modalities were safe (no significant adverse events recorded) and associated with a significant improvement in V ˙ O2peak as compared to controls: age and baseline V ˙ O2peak-adjusted end-of-study V ˙ O2peak increased to 16.7 (95% CI 16.0-17.4) ml kg-1 min-1 with land-based training (p < 0.001 for change from baseline) and to 18.6 (95% CI 17.9-19.3) ml kg-1 min-1 with water-based training (p < 0.001 for change from baseline), but not in controls (14.9 ml kg-1 min-1; 95% CI 14.2-15.6; p = 0.775 for change from baseline). FMD also increased in both intervention groups (from 5.5 to 8.8%, p < 0.001 with land-based, and from 7.2 to 9.2%, p < 0.001 with water-based training, respectively), as compared to controls (p for change 0.629). No significant changes were detected in biomarkers of inflammation, cell adhesion or hemostasis, whereas levels of NT-proBNP (marker of cardiac dysfunction) decreased in the water-based training group (p = 0.07 vs. controls). CONCLUSION: Endurance plus calisthenics exercise training in thermo-neutral water is safe, and improves aerobic exercise capacity and vascular function in patients undergoing short-term residential cardiac rehabilitation after a recent CAD event. CLINICAL TRIAL REGISTRATION: www.ClinicalTrials.gov, identifier NCT02831829.

The efficacy and safety of valsartan and a combination of valsartan and hydrochlorothiazide in the treatment of patients with mild to moderate arterial hypertension: a subgroup analysis of the effect of valsartan and its combination with .

BACKGROUND AND AIM: The aim of the study was to establish the effect of valsartan and combination of valsartan and hydrochlorothiazide (HCTZ) on pulse wave velocity (PWV) and central blood pressure (CBP) in a large population of patients with mild to moderate arterial hypertension. METHODS: This was an international, multicentre, open-label, prospective trial. After one week of washout in previously treated patients, 74 subjects were treated with valsartan or valsartan combined with HCTZ for 16 weeks according to the protocol. Naïve patients received the treatment immediately. During the active treatment, four visits were planned for each patient to obtain data for the primary and secondary efficacy. At the beginning and at the end of the study PWV and CBP were determined with central arterial pressure waveform analysis (SphygmoCor®, Atcor Medical). This study is registered with clinicaltrialsregister.eu, EudraCT number 2012-005129-57. RESULTS: The results of the present VICTORY trial showed that valsartan and combination of valsartan and HCTZ effectively reduced the brachial blood pressure in patients with mild to moderate arterial hypertension as well as PWV, central systolic blood pressure and central diastolic blood pressure. The effects on the augmentation index were not statistically significant. CONCLUSIONS: Valsartan and valsartan/HCTZ improve arterial stiffness in patients with mild to moderate hypertension.

Survival and event-free survival of patients with peripheral arterial disease undergoing prevention of cardiovascular disease.

BACKGROUND: Patients with peripheral arterial disease (PAD) are at very high risk for cardiovascular events. How do patients with PAD differ from age- and sex-matched controls in survival, major ischemic events and revascularization procedures when both groups were managed according to the European guidelines on cardiovascular disease prevention? METHODS: Patients with PAD (N.=742) and 713 age and sex-matched control subjects without PAD, both groups aged 65±9 years at inclusion, were managed for 5 years according to the European guidelines on cardiovascular disease prevention and evaluated yearly for occurrence of death, non-fatal major ischemic events and revascularization procedures (minor events). RESULTS: In the PAD group, the 5-year survival was 84.7% (CI 82.1-87.3%) vs. 93.3% (CI 91.5-95.2%) in the control group, P<0.001. In the PAD group the proportion of cardiovascular deaths did not differ significantly from non-cardiovascular deaths (6.9 vs. 8.4%, P=0.14), while in the control group cardiovascular deaths were less frequent (2.4 vs. 4.3%, P=0.05). The groups differed in 5-year major event-free survival: 76.7% (CI 73.7-79.8%) in PAD vs. 89.9% (CI 87.7 -92.2%) in controls, P<0.001, and in event-free survival: 56.2% (CI 52.7-59.9%) in PAD vs. 82.4% (CI 79.9-85.3%) in controls, P<0.001. CONCLUSIONS: Patients with PAD had a higher risk of all-cause death, major and minor non-fatal cardiovascular events compared to control subjects. In our group, cardiovascular events were not the leading cause of death in patients with PAD (ClinicalTrials.gov number NCT00761969.).

The efficacy and safety of valsartan and combination of valsartan and hydrochlorothiazide in the treatment of patients with mild to moderate arterial hypertension - the VICTORY trial.

BACKGROUND AND AIM: The aim of the trial was to establish the efficacy and safety of Valsacor® (valsartan) and Valsacombi® (combination of valsartan and hydrochlorothiazide) in a wide variety of patient populations with mild to moderate arterial hypertension. METHODS: We performed an international, multicentre, open-label, prospective trial. After one week of washout in previously treated patients, the patients were treated for 16 weeks according to the protocol. Naïve patients entered the treatment period immediately. During the active treatment, four visits were planned for each patient to obtain the data for the primary and secondary efficacy endpoints analysis. The principal methods were blood pressure (BP) measurement, additionally in a subgroup of patients, assessment of erectile function. The initial dosage of valsartan 80 mg/day was titrated up to 320 mg/day to achieve the BP goal, with the addition of hydrochlorothiazide (HCTZ) in a fixed-dose combination (FDC), if needed. RESULTS: Mean ± standard deviation changes from baseline at week 16 were -26.6 ± 10.4 mm Hg (systolic BP) and -14.8 ± 7.6 mm Hg (diastolic BP). A total of 91% of the patients treated with either valsartan or valsartan FDC achieved the BP goal. Adverse reactions were experienced by 7.1% of the patients, with the most common being headache (1.9%), palpitation (1.6%), dizziness (1.6%), and fatigue (1.6%), during the whole trial. CONCLUSIONS: The results of the VICTORY trial show that valsartan and valsartan FDC effectively reduce the BP in patients with mild to moderate arterial hypertension and have a good tolerability profile.