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Exercise training in Diastolic Heart Failure

Exercise training in Diastolic Heart Failure: A prospective, randomized, controlled study to determine the effects of exercise training in patients with heart failure and preserved ejection fraction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN86879094
Enrollment
320
Registered
2011-10-06
Start date
2011-12-21
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure with preserved ejection fraction (HFpEF, i.e. diastolic heart failure) Circulatory System Congestive heart failure

Interventions

Experimental intervention: individually prescribed, supervised, combined endurance / strength training for 12 months (=3x/ week) Control intervention: usual care

Sponsors

Georg-August University of Gottingen (Georg-August-Unversitat Gottingen) (Germany)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 110 Years

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 15, 2026