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

NCT04696900 | Unknown

• 1 other identifier: REHAB-HF/VAD
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

advanced heart failure; ventricular assist device; exercise training; cardiac rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• rehospitalization rates

  12 months before training and 12 months while training

• heart failure biomarkers

  after 6 and 12 months

• Renal function biomarker: Creatinin

  after 6 and 12 months

• Renal function biomarkers: glomerular Filtration rate

  after 6 and 12 months

• Hepatic function biomarkers: transaminases

  after 6 and 12 months

Study Arms (1)

Exercise training

OTHER

14 participants will absolve a prescribed exercise training for 12 months.

Procedure: Exercise training

Interventions

Exercise training PROCEDURE

exercise training in an approved rehabilitation program

Exercise training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• German Heart Institute: lead

Study Sites (1)

German Heart Institute

Berlin, 13353, Germany

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Exercise

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• I A Just

  German Heart Institute

  PRINCIPAL INVESTIGATOR

• F Schoenrath

  German Heart Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

I A Just

CONTACT

00493045932025; ijust@dhzb.de

F Schoenrath

CONTACT

00493045932085; schoenrath@dhzb.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: January 6, 2021
• Study Start: June 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 19, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)