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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
German Heart Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 4, 2020
Last Updated
November 16, 2021
Sponsor
German Heart Institute
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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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