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

NCT ID: NCT04696900

Last Updated: 2021-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure

Keywords

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advanced heart failure ventricular assist device exercise training cardiac rehabilitation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise training

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

Group Type OTHER

Exercise training

Intervention Type PROCEDURE

exercise training in an approved rehabilitation program

Interventions

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Exercise training

exercise training in an approved rehabilitation program

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Heart Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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I A Just

Role: PRINCIPAL_INVESTIGATOR

German Heart Institute

F Schoenrath

Role: PRINCIPAL_INVESTIGATOR

German Heart Institute

Locations

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German Heart Institute

Berlin, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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I A Just

Role: CONTACT

Phone: 00493045932025

Email: [email protected]

F Schoenrath

Role: CONTACT

Phone: 00493045932085

Email: [email protected]

Facility Contacts

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I A Just

Role: primary

F Schoenrath

Role: backup

Other Identifiers

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REHAB-HF/VAD

Identifier Type: -

Identifier Source: org_study_id