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

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

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure
• Intervention / Treatment: Procedure: Exercise training

• Study Type: Interventional
• Enrollment (Anticipated): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Recruiting
    • German Heart Institute
    • Contact: I A Just; Phone Number: 00493045932025; Email: ijust@dhzb.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2020
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: February 4, 2020
• First Submitted That Met QC Criteria: January 4, 2021
• First Posted (ACTUAL): January 6, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 19, 2021
• Last Update Submitted That Met QC Criteria: November 16, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: exercise training; cardiac rehabilitation; ventricular assist device; advanced heart failure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: REHAB-HF/VAD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No