Heart failure with preserved ejection fraction (HFpEF, i.e. diastolic heart failure) Circulatory System Congestive heart failure
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Stable symptomatic heart failure with preserved ejection fraction (diagnosis according to criteria of the European Society of Cardiology: Paulus et al., 2007): 1.1. New York Heart Association (NYHA) II-III, peak VO2 15 or (E/e') > 8 220 ng/L 1.5. Atrial fibrillation 2. Age =18 years 3. Symptom severity and heart failure medication were stable during the last 4 weeks 4. Written informed consent of the patient
Exclusion criteria
Exclusion criteria: 1. Non-cardiac causes for heart failure like symptoms: 1.1. Chronic obstructive pulmonary disease (COPD) - Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages = II (moderate, severe, very severe) 1.2. Anaemia (=140/90mmHg or BP >= 160/100mmHg with >= 3 antihypertensive drugs) or of resting heart rate (HR >= 100bpm) 5. Expected low compliance (e.g. by travel distance to trial site; planned absences longer than 4 weeks during follow up) or ongoing drug abuse 6. Concomitant participation in other interventional clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined outcome score (modified ?Packer score?, Packer et al., 2001). This combined score classifies patients as: 1 (worsened), 0 (unchanged) or +1 (improved). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Components of the primary endpoint (all cause mortality, cardiovascular hospitalisations, change in NYHA-Class, change in global self-assessment, change in peak VO2, change in E/e') 2. Change in echocardiographic parameters of diastolic function [LAVI, Grad of diastolic function, E/e´, e´, ratio between early (E) and late (atrial - A) ventricular filling velocity (E/A), deceleration time (DT), isovolumic relaxation time (IVRT)], systolic function (LVEF), left ventricular dimensions (LVEDD, LVESD) and structure (LVMI) after 6 and 12 months 3. Change in quality of life (SF-36, MLWHFQ, HADS) after 6 and 12 months 4. Change in ventilatory efficacy (VE/VCO2) and sub-maximal exercise capacity (anaerobic threshold, 6-min walk distance) after 6 and 12 months 5. Change in neurohumoral activation (NT-proBNP) after 6 and 12 months 6. Safety and tolerability of training intervention 7. Gender aspects of all primary and secondary endpoints | — |
Countries
Austria, Germany