Diastolic heart failure Circulatory System Heart disease
Conditions
Interventions
Once randomised, patients will either participate in an combined endurance and strength exercise training two to three times/week for three months or perform their usual activities. After three months
Sponsors
Georg-August University of Gottingen (Georg-August-Unversitat Gottingen) (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. At least one of the following risk factors for the development of a diastolic dysfunction: 1.1. Diabetes 1.2. Hypertension 1.3. Smoking 1.4. Hyperlipidaemia 1.5. Overweight 2. Aged greater than or equal to 45 years 3. Written informed consent 4. New York Heart Association (NYHA) II or III 5. Diastolic dysfunction greater than or equal to grade one (echocardiographically determined) 6. Left Ventricular Ejection Fraction (LVEF) greater than or equal to 50%
Exclusion criteria
Exclusion criteria: 1. Diseases limiting the validity of consent (psychiatric diseases, dementia etc.,) 2. Change in medication within the last two weeks 3. Limited exercise capacity due to musculo-skeletal diseases or pulmonary disease 4. Myocardial Infarction (MI) or bypass surgery in the patient's history or clinically significant Coronary Artery Disease (CAD) (angina or known untreated stenosis of more than 50%) or peripheral arterial obstructive disease greater than or equal to IIa 5. Pregnant or nursing women and women before menopause without sufficient contraception 6. Participaton in another study currently or within the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in peak maximal oxygen uptake (VO2), measured at 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in quality of life 2. Change in early left ventricular filling-to-peak early diastolic myocardial velocity ratio (E/E' ratio) 3. Change in six-minute walking distance 4. Change in N-Terminal pro-B-type Natriuretic Peptide (NT-proBNP) and other parameters of neurohumoral activation 5. Change in Heart Rate Variability (HRV) and Heart Rate Turbulence (HRT) 6. Change in blood levels of parameters of collagen turnover, metabolic syndrome and inflammation 7. Change in parameters of diastolic dysfunction: 7.1. Early-to-Atrial left ventricular filling ratio (E/A ratio) 7.2. Early left ventricular filling Deceleration Time (EDT) 7.3. Isovolumic Relaxation Time (IVRT) 7.4. Systolic-to-Diastolic pulmonary venous flow ratio (S/D ratio) 7.5. Pulmonary Venous peak Atrial contraction Reversed velocity (PVAR) 7.6. Colour M-Mode flow propagation Velocity (Vp) 7.7. Doppler echocardiography-derived index of myocardial performance (TEI-Index) 7.8. Left Ventricular mass (LV-mass) 7.9. Left Ventricular volume (LV-volume) 7.10. Left Atrial volume (LA-volume) 8. Severity of diastolic dysfunction (echocardiography) 9. Change in endothelial function, safety, compliance, cardiovascular morbidity and mortality Secondary outcomes are measured at 3 and 6 months | — |
Countries
Germany
Outcome results
None listed