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

Not Applicable

• Conditions: Heart Failure

• Registration Number: NCT04696900
• Lead Sponsor: German Heart Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-04
• Study Start: 2020-06-01
• Status Verified: 2020-12
• Study First Submitted QC: 2021-01-04
• Study First Posted: 2021-01-06
• Last Update Submitted: 2021-11-16
• Last Update Posted: 2021-11-19
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
Renal function biomarkers: glomerular Filtration rate	after 6 and 12 months	Change in biomarkers of renal function: glomerular filtration rate
Hepatic function biomarkers: transaminases	after 6 and 12 months	Change in biomarkers of hepatic function: transaminases
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
Heart failure Progression: Ejection fractions	after 6 and 12 months	Change of echocardiographic findings: ejection fraction (in %)
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 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 biomarkers	after 6 and 12 months	Change in biomarkers of heart failure: NTproBNP

Trial Locations

Locations (1)

German Heart Institute; 🇩🇪 Berlin, Germany