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

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04696900
• Other study ID #: REHAB-HF/VAD
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: December 2022

Study information

• Verified date: December 2020
• Source: German Heart Institute
• Contact: I A Just
• Phone: 00493045932025
• Email: ijust[@]dhzb.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Procedure:
• Exercise training
exercise training in an approved rehabilitation program

Locations

Country	Name	City	State
Germany	German Heart Institute	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
German Heart Institute

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	heart failure biomarkers	Change in biomarkers of heart failure: NTproBNP	after 6 and 12 months
Secondary	Renal function biomarker: Creatinin	Change in biomarkers of renal function: creatinin	after 6 and 12 months
Secondary	Renal function biomarkers: glomerular Filtration rate	Change in biomarkers of renal function: glomerular filtration rate	after 6 and 12 months
Secondary	Hepatic function biomarkers: transaminases	Change in biomarkers of hepatic function: transaminases	after 6 and 12 months
Secondary	Hepatic function biomarkers: gamma-glutamyltransferase	Change in biomarkers of hepatic function: gamma-glutamyltransferase	after 6 and 12 months
Secondary	Heart failure Progression: Ejection fractions	Change of echocardiographic findings: ejection fraction (in %)	after 6 and 12 months
Secondary	Heart failure Progression: Diameters	Change of echocardiographic findings: diameters (in mm)	after 6 and 12 months
Secondary	Heart failure Progression: Aortic Valve opening	Change of echocardiographic findings: aortic valve opening	after 6 and 12 months
Secondary	Heart failure Progression: Valvular regurgitations	Change of echocardiographic findings: Valvular regurgitation (in grades I-III°)	after 6 and 12 months