Effect of Prescribed Cardiac Rehabilitation in Patients With Advanced Heart Failure or Ventricular Assist Device

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Heart Failure

Intervention / Treatment
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* Procedure: Exercise training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Exercise training<br>14 participants will absolve a prescribed exercise training for 12 months. | Procedure: Exercise training<br>* exercise training in an approved rehabilitation program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of exercise training in severe heart failure as assessed by quality of life | Change of quality of life by Kansas City Cardiomyopathy Questionnaire | after 3, 6 and 12 months | 
| Efficacy of exercise training in severe heart failure as assessed by exercise capacity | Change of exercise capacity measured by six-minute walking distance in meters | after 3, 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rehospitalization rates | Change in rehospitalization rate or unplanned outpatient healthcare visits due to symptoms of heart failure measured by a final visit and record screening | 12 months before training and 12 months while training | 
| heart failure biomarkers | Change in biomarkers of heart failure: NTproBNP | after 6 and 12 months | 
| Renal function biomarker: Creatinin | Change in biomarkers of renal function: creatinin | after 6 and 12 months | 
| Renal function biomarkers: glomerular Filtration rate | Change in biomarkers of renal function: glomerular filtration rate | after 6 and 12 months | 
| Hepatic function biomarkers: transaminases | Change in biomarkers of hepatic function: transaminases | after 6 and 12 months | 
| Hepatic function biomarkers: gamma-glutamyltransferase | Change in biomarkers of hepatic function: gamma-glutamyltransferase | after 6 and 12 months | 
| Heart failure Progression: Ejection fractions | Change of echocardiographic findings: ejection fraction (in %) | after 6 and 12 months | 
| Heart failure Progression: Diameters | Change of echocardiographic findings: diameters (in mm) | after 6 and 12 months | 
| Heart failure Progression: Aortic Valve opening | Change of echocardiographic findings: aortic valve opening | after 6 and 12 months | 
| Heart failure Progression: Valvular regurgitations | Change of echocardiographic findings: Valvular regurgitation (in grades I-III°) | after 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac rehabilitation, advanced heart failure, ventricular assist device, exercise training