Effect of Prescribed Cardiac Rehabilitation in Patients With Advanced Heart Failure or Ventricular Assist Device
Primary Purpose
Heart Failure
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Exercise training
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring advanced heart failure, ventricular assist device, exercise training, cardiac rehabilitation
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
Sites / Locations
- German Heart InstituteRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Exercise training
Arm Description
14 participants will absolve a prescribed exercise training for 12 months.
Outcomes
Primary Outcome Measures
Efficacy of exercise training in severe heart failure as assessed by quality of life
Change of quality of life by Kansas City Cardiomyopathy Questionnaire
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
Secondary Outcome Measures
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
heart failure biomarkers
Change in biomarkers of heart failure: NTproBNP
Renal function biomarker: Creatinin
Change in biomarkers of renal function: creatinin
Renal function biomarkers: glomerular Filtration rate
Change in biomarkers of renal function: glomerular filtration rate
Hepatic function biomarkers: transaminases
Change in biomarkers of hepatic function: transaminases
Hepatic function biomarkers: gamma-glutamyltransferase
Change in biomarkers of hepatic function: gamma-glutamyltransferase
Heart failure Progression: Ejection fractions
Change of echocardiographic findings: ejection fraction (in %)
Heart failure Progression: Diameters
Change of echocardiographic findings: diameters (in mm)
Heart failure Progression: Aortic Valve opening
Change of echocardiographic findings: aortic valve opening
Heart failure Progression: Valvular regurgitations
Change of echocardiographic findings: Valvular regurgitation (in grades I-III°)
Full Information
NCT ID
NCT04696900
First Posted
February 4, 2020
Last Updated
November 16, 2021
Sponsor
German Heart Institute
1. Study Identification
Unique Protocol Identification Number
NCT04696900
Brief Title
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
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
German Heart Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
advanced heart failure, ventricular assist device, exercise training, cardiac rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise training
Arm Type
Other
Arm Description
14 participants will absolve a prescribed exercise training for 12 months.
Intervention Type
Procedure
Intervention Name(s)
Exercise training
Intervention Description
exercise training in an approved rehabilitation program
Primary Outcome Measure Information:
Title
Efficacy of exercise training in severe heart failure as assessed by quality of life
Description
Change of quality of life by Kansas City Cardiomyopathy Questionnaire
Time Frame
after 3, 6 and 12 months
Title
Efficacy of exercise training in severe heart failure as assessed by exercise capacity
Description
Change of exercise capacity measured by six-minute walking distance in meters
Time Frame
after 3, 6 and 12 months
Secondary Outcome Measure Information:
Title
rehospitalization rates
Description
Change in rehospitalization rate or unplanned outpatient healthcare visits due to symptoms of heart failure measured by a final visit and record screening
Time Frame
12 months before training and 12 months while training
Title
heart failure biomarkers
Description
Change in biomarkers of heart failure: NTproBNP
Time Frame
after 6 and 12 months
Title
Renal function biomarker: Creatinin
Description
Change in biomarkers of renal function: creatinin
Time Frame
after 6 and 12 months
Title
Renal function biomarkers: glomerular Filtration rate
Description
Change in biomarkers of renal function: glomerular filtration rate
Time Frame
after 6 and 12 months
Title
Hepatic function biomarkers: transaminases
Description
Change in biomarkers of hepatic function: transaminases
Time Frame
after 6 and 12 months
Title
Hepatic function biomarkers: gamma-glutamyltransferase
Description
Change in biomarkers of hepatic function: gamma-glutamyltransferase
Time Frame
after 6 and 12 months
Title
Heart failure Progression: Ejection fractions
Description
Change of echocardiographic findings: ejection fraction (in %)
Time Frame
after 6 and 12 months
Title
Heart failure Progression: Diameters
Description
Change of echocardiographic findings: diameters (in mm)
Time Frame
after 6 and 12 months
Title
Heart failure Progression: Aortic Valve opening
Description
Change of echocardiographic findings: aortic valve opening
Time Frame
after 6 and 12 months
Title
Heart failure Progression: Valvular regurgitations
Description
Change of echocardiographic findings: Valvular regurgitation (in grades I-III°)
Time Frame
after 6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
I A Just
Phone
00493045932025
Email
ijust@dhzb.de
First Name & Middle Initial & Last Name or Official Title & Degree
F Schoenrath
Phone
00493045932085
Email
schoenrath@dhzb.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
I A Just
Organizational Affiliation
German Heart Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
F Schoenrath
Organizational Affiliation
German Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
German Heart Institute
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
I A Just
Phone
00493045932025
Email
ijust@dhzb.de
First Name & Middle Initial & Last Name & Degree
F Schoenrath
Phone
00493045932085
Email
schoenrath@dhzb.de
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Prescribed Cardiac Rehabilitation in Patients With Advanced Heart Failure or Ventricular Assist Device
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