Clinical trial NCT04696900: Effect of Prescribed Cardiac Rehabilitation in Patients With Advanced Heart Failure or Ventricular Assist Device
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Keywords: advanced heart failure
ventricular assist device
exercise training
cardiac rehabilitation
Lead sponsor: German Heart Institute
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of exercise training in severe heart failure as assessed by quality of life
timeFrame: after 3, 6 and 12 months
measure: Efficacy of exercise training in severe heart failure as assessed by exercise capacity
timeFrame: after 3, 6 and 12 months
Secondary outcomes:
measure: rehospitalization rates
timeFrame: 12 months before training and 12 months while training
measure: heart failure biomarkers
timeFrame: after 6 and 12 months
measure: Renal function biomarker: Creatinin
timeFrame: after 6 and 12 months
measure: Renal function biomarkers: glomerular Filtration rate
timeFrame: after 6 and 12 months
measure: Hepatic function biomarkers: transaminases
timeFrame: after 6 and 12 months
measure: Hepatic function biomarkers: gamma-glutamyltransferase
timeFrame: after 6 and 12 months
measure: Heart failure Progression: Ejection fractions
timeFrame: after 6 and 12 months
measure: Heart failure Progression: Diameters
timeFrame: after 6 and 12 months
measure: Heart failure Progression: Aortic Valve opening
timeFrame: after 6 and 12 months
measure: Heart failure Progression: Valvular regurgitations
timeFrame: after 6 and 12 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: German Heart Institute
Study officials:
affiliation: German Heart Institute
name: I A Just
role: PRINCIPAL_INVESTIGATOR
affiliation: German Heart Institute
name: F Schoenrath
role: PRINCIPAL_INVESTIGATOR
References: