Heart insufficiency
Conditions
Interventions
Group 1: In this clinical study, the effectiveness of regular physical training on patients with heart failure with preserved left ventricular ejection fraction (HFpEF) is investigated by comparing a
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Age = 18 years 2) Written informed consent 3) Presence of signs and symptoms of heart failure corresponding to a NYHA class = 2. 4) Echocardiographically preserved ejection fraction (LVEF = 50%). 5) NTproBNP >125 (SR) or >365 (VHFL) pg/mL or BNP >35 (SR) or >105 (VHL) pg/mL. 6) Existence of structural or functional cardiac changes compatible with LV diastolic dysfunction or elevated left ventricular filling pressures, respectively. Applicability of at least one of the following echocardiographic or invasive criteria: - LV mass index = 95 g/m2 (women), >_115 g/m2 (men) and relative wall thickness >0.42 - LA volume index > 34mL/m2 (SR) or > 40 ml/m2 (VHFL). - E/e' ratio at rest = 13 - PA systolic pressure >35 mmHg (invasive under stress). - TR velocity at rest > 2.8 m/s (invasive under stress)
Exclusion criteria
Exclusion criteria: 1) Life expectancy 2) or severe anemia (Hb<10g/dl in men and Hb <9.5g/dl in women).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum exercise capacity (peakVO2, measured by spiroergometry) after 12 weeks of training or control intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change in ventilatory efficiency (VE/VCO2 slope) and submaximal performance (distance in 6-minute walk test, anaerobic threshold) - Change in muscle strength (e.g. measured by hand grip) - Change in body composition - Change in quality of life (e.g. KCCQ, SF-36) Change in cognition (e.g. PROMs, CANTAB) -Change in echocardiographic parameters of cardiac (left and right heart) morphology and function at rest and during exercise - Changes in markers of neuroendocrine activation (e.g. NT-proBNP), inflammation, collagen turnover and fibrosis as well as metabolic parameters - Frailty in the context of the cardiac support system and the interaction with training - Long-term effects of training - Change in daily physical activity - Adherence to training plans - Safety and tolerability of the training intervention Gender-relevant aspects of all primary and secondary endpoints | — |
Countries
Germany
Contacts
Public ContactFrank Edelmann
Deutsches Herzzentrum der Charité Klinik für Kardiologie, Angiologie und Intensivmedizin Campus Virchow-Klinikum
Outcome results
None listed