Exercise training in Diastolic Heart Failure

• Register: ISRCTN
• Last refreshed on: 22 January 2024
• Main ID: ISRCTN86879094
• Date of registration: 06/10/2011
• Prospective Registration: Yes
• Primary sponsor: Georg-August University of Gottingen (Georg-August-Unversitat Gottingen) (Germany)
• Public title: Exercise training in Diastolic Heart Failure
• Scientific title: 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
• Date of first enrolment: 21/12/2011
• Target sample size: 320
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN86879094
• Study type: Interventional
• Study design: Multicenter prospective parallel-group randomized controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Austria, Germany

Contacts

• Name: Frank Edelmann

Key inclusion & exclusion 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 < 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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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

Control intervention: usual care

Primary Outcome(s)

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(s)

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

Secondary ID(s)

Version 1.0 valid from 04.08.2011 (22/8/11)

Source(s) of Monetary Support

German Research Foundation (DFG) (Germany) (ref: ED 196/2-1, GE 2048/2-1, HA 5812/4-1)

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; Ethics Committee University of Göttingen, Germany and all responsible local (trial sites) ethics committees approved on 5th September 2011

Results

• Results available: Yes
• Date Completed: 31/08/2015