Heart Failure
Conditions
Keywords
advanced heart failure, ventricular assist device, exercise training, cardiac rehabilitation
Brief summary
This trial will evaluate the effect of prescribed exercise training on quality of life and exercise capacity of patients with advanced heart failure or after ventricular assist device implantation. Furthermore, clinical, laboratory and echocardiographic markers of heart failure, rehospitalization rates and cost-effectiveness will be assessed.
Interventions
PROCEDUREExercise training
exercise training in an approved rehabilitation program
Sponsors
German Heart Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age \>17 years * written informed consent * chronic end-stage systolic heart failure with or without ventricular assist device * clinically stable for at least 6 weeks * prescription of cardiac rehabilitation
Exclusion criteria
* addictions or other illnesses that impact the ability to understand the nature, scope and consequences of the trial * lack of knowledge of German to fully understand study information * pregnancy, pre-menopausal women * participation in the rehabilitation program \< 80% * contraindications of cardiopulmonary exercise testing on an ergometer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of exercise training in severe heart failure as assessed by quality of life | after 3, 6 and 12 months | Change of quality of life by Kansas City Cardiomyopathy Questionnaire |
| Efficacy of exercise training in severe heart failure as assessed by exercise capacity | after 3, 6 and 12 months | Change of exercise capacity measured by six-minute walking distance in meters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rehospitalization rates | 12 months before training and 12 months while training | Change in rehospitalization rate or unplanned outpatient healthcare visits due to symptoms of heart failure measured by a final visit and record screening |
| heart failure biomarkers | after 6 and 12 months | Change in biomarkers of heart failure: NTproBNP |
| Renal function biomarker: Creatinin | after 6 and 12 months | Change in biomarkers of renal function: creatinin |
| Hepatic function biomarkers: gamma-glutamyltransferase | after 6 and 12 months | Change in biomarkers of hepatic function: gamma-glutamyltransferase |
| Renal function biomarkers: glomerular Filtration rate | after 6 and 12 months | Change in biomarkers of renal function: glomerular filtration rate |
| Heart failure Progression: Diameters | after 6 and 12 months | Change of echocardiographic findings: diameters (in mm) |
| Heart failure Progression: Aortic Valve opening | after 6 and 12 months | Change of echocardiographic findings: aortic valve opening |
| Heart failure Progression: Valvular regurgitations | after 6 and 12 months | Change of echocardiographic findings: Valvular regurgitation (in grades I-III°) |
| Heart failure Progression: Ejection fractions | after 6 and 12 months | Change of echocardiographic findings: ejection fraction (in %) |
| Hepatic function biomarkers: transaminases | after 6 and 12 months | Change in biomarkers of hepatic function: transaminases |
Countries
Germany
Contacts
Primary ContactI A Just
Backup ContactF Schoenrath
Outcome results
None listed