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Cardiovascular Effects of Preferred Home-based Exercise Training in Systolic Heart Failure

NCT ID: NCT02051712

Last Updated: 2023-12-12

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

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2024-12-31

Brief Summary

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The aim of the study is I. To assess whether an individualized exercise training program is superior as compared to usual care with respect to exercise tolerance, II. to assess whether intervention tools that aim to increase exercise adherence are superior to an individualized exercise training alone with respect to exercise tolerance and long-term effects, and III. to identify biomarkers that that may be implemented into novel intervention tools aiming to increase exercise adherence in patients with chronic heart failure.

Detailed Description

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Conditions

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Chronic Heart Failure

Keywords

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chronic heart failure exercise training preferred training prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Usual care

Usual car accruing to guidelines

Group Type NO_INTERVENTION

No interventions assigned to this group

Individualized training

Individualized exercise training program in addition to usual care

Group Type EXPERIMENTAL

exercise training

Intervention Type BEHAVIORAL

individualized exercise training

Individualized training plus adherence measures

Individualized exercise training plus measures to increase adherence

Group Type EXPERIMENTAL

exercise training

Intervention Type BEHAVIORAL

individualized exercise training

Adherence measures

Intervention Type BEHAVIORAL

Measures to increase adherence to exercise training

Interventions

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exercise training

individualized exercise training

Intervention Type BEHAVIORAL

Adherence measures

Measures to increase adherence to exercise training

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* women and men
* age 30-75 years
* chronic heart failure (NYHA II/III), left ventricular ejection fraction ≤40% be echo
* disease duration ≥ 6 month
* medical therapy accruing to guidelines (drug, devices, including CRT)
* written informed consent

Exclusion Criteria

* acute myocarditis
* instable angina
* heart surgery (e.g. ICD implantation, bypass) with last 6 weeks; CRT implantation within the last 6 months before study start
* severe cardiovascular events (myocardial infarction, cardiac decompensation, ICD shock, PCI due to instable angina) \< 6 weeks before study start
* preplanned hospital admission or intervention (e.g. planned revascularization, ICD implantation)
* uncorrected valve regurgitation or stenosis (\> second degree)
* safety concerns regarding or other reasons against exercise training
* severe depression
* regular exercise training within the last 6 weeks
* life expectancy \< 1 year
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

OTHER

Sponsor Role collaborator

University Medicine Greifswald

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marcus Dörr, MD

Role: PRINCIPAL_INVESTIGATOR

University Greifswald

Locations

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Marcus Dörr

Greifswald, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Marcus Dörr, MD

Role: CONTACT

Phone: +49 3834 8680500

Email: [email protected]

Stepahn B Felix, MD

Role: CONTACT

Phone: +4938348680500

Email: [email protected]

Facility Contacts

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Marcus Dörr, MD

Role: primary

Stephan B Felix, MD

Role: backup

Other Identifiers

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DZHK-HGW-001

Identifier Type: -

Identifier Source: org_study_id