NCT04696900
Unknown
Not Applicable
Examination of the Effect of Prescribed Cardiac Rehabilitation on Quality of Life, Exercise Capacity and Course of Disease in Patients With Advanced Heart Failure or After Ventricular Assist Device Implantation
German Heart Institute1 site in 1 country14 target enrollmentJune 1, 2020
ConditionsHeart Failure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- German Heart Institute
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Efficacy of exercise training in severe heart failure as assessed by exercise capacity
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Efficacy of exercise training in severe heart failure as assessed by exercise capacity
Time Frame: after 3, 6 and 12 months
Change of exercise capacity measured by six-minute walking distance in meters
Efficacy of exercise training in severe heart failure as assessed by quality of life
Time Frame: after 3, 6 and 12 months
Change of quality of life by Kansas City Cardiomyopathy Questionnaire
Secondary Outcomes
- Renal function biomarkers: glomerular Filtration rate(after 6 and 12 months)
- Hepatic function biomarkers: transaminases(after 6 and 12 months)
- heart failure biomarkers(after 6 and 12 months)
- Renal function biomarker: Creatinin(after 6 and 12 months)
- Hepatic function biomarkers: gamma-glutamyltransferase(after 6 and 12 months)
- Heart failure Progression: Ejection fractions(after 6 and 12 months)
- rehospitalization rates(12 months before training and 12 months while training)
- Heart failure Progression: Diameters(after 6 and 12 months)
- Heart failure Progression: Aortic Valve opening(after 6 and 12 months)
- Heart failure Progression: Valvular regurgitations(after 6 and 12 months)
Study Sites (1)
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