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

• Sponsor: German Heart Institute (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04696900
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 30
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Procedure: Exercise training	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Jun 1, 2020
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Exercise training 14 participants will absolve a prescribed exercise training for 12 months.	Procedure: Exercise training; exercise training in an approved rehabilitation program

Outcome Measures

Primary Outcome Measures

1. 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

2. 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 Outcome Measures

1. 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

2. heart failure biomarkers [after 6 and 12 months]

   Change in biomarkers of heart failure: NTproBNP

3. Renal function biomarker: Creatinin [after 6 and 12 months]

   Change in biomarkers of renal function: creatinin

4. Renal function biomarkers: glomerular Filtration rate [after 6 and 12 months]

   Change in biomarkers of renal function: glomerular filtration rate

5. Hepatic function biomarkers: transaminases [after 6 and 12 months]

   Change in biomarkers of hepatic function: transaminases

6. Hepatic function biomarkers: gamma-glutamyltransferase [after 6 and 12 months]

   Change in biomarkers of hepatic function: gamma-glutamyltransferase

7. Heart failure Progression: Ejection fractions [after 6 and 12 months]

   Change of echocardiographic findings: ejection fraction (in %)

8. Heart failure Progression: Diameters [after 6 and 12 months]

   Change of echocardiographic findings: diameters (in mm)

9. Heart failure Progression: Aortic Valve opening [after 6 and 12 months]

   Change of echocardiographic findings: aortic valve opening

10. Heart failure Progression: Valvular regurgitations [after 6 and 12 months]

    Change of echocardiographic findings: Valvular regurgitation (in grades I-III°)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	German Heart Institute	Berlin		Germany	13353

Sponsors and Collaborators

• German Heart Institute

Investigators

• Principal Investigator: I A Just, German Heart Institute
• Principal Investigator: F Schoenrath, German Heart Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: German Heart Institute
• ClinicalTrials.gov Identifier: NCT04696900
• Other Study ID Numbers: REHAB-HF/VAD
• First Posted: Jan 6, 2021
• Last Update Posted: Nov 19, 2021
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by German Heart Institute: advanced heart failure; ventricular assist device; exercise training; cardiac rehabilitation
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Nov 19, 2021