Exercise training in Diastolic Heart Failure

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 320

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 < 25 ml/kg/min
1.2. Left ventricular ejection fraction (LVEF) = 50%
1.3. Ratio of early transmitral flow velocity (E) to early diastolic mitral annular velocity (E') (E/e)' > 15 or (E/e') > 8 < 15
1.4. N-terminal pro-B-type natriuretic peptide (NTproBNP) > 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

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 (<11mg/dl)
1.3. Significant renal dysfunction estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73m^2 body surface area (BSA)
1.4. Significant peripheral artery disease (Fontaine = IIb)
1.5. Musculoskeletal disease that contribute to reduced exercise performance
1.6. Specific cardiomyopathy (e.g. amyloidosis etc.)
1.7. Haemodynamically significant valvular disorders
2. Significant coronary artery disease (CAD) [current angina pectoris, Canadian Cardiovascular Society (CCS) = II or positive stresstest, myocardial infarction or coronary artery bypass graft within the last 3 months)
3. Any inability or contraindication to participate in ergospirometric testing or in an exercise program (e.g. physiological, mental) or supply essential information (e.g. questionnaire, diary)
4. Ineffective control of resting blood pressure (BP >=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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Combined outcome score (modified ?Packer score?, Packer et al., 2001). This combined score classifies patients as: 1 (worsened), 0 (unchanged) or +1 (improved).

Secondary Outcome Measures

Name	Time	Method
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')<br>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 <br>3. Change in quality of life (SF-36, MLWHFQ, HADS) after 6 and 12 months <br>4. Change in ventilatory efficacy (VE/VCO2) and sub-maximal exercise capacity (anaerobic threshold, 6-min walk distance) after 6 and 12 months <br>5. Change in neurohumoral activation (NT-proBNP) after 6 and 12 months<br>6. Safety and tolerability of training intervention<br>7. Gender aspects of all primary and secondary endpoints

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