Exercise Training in Treating Diastolic Heart Failure

NCT ID: NCT02155842

Last Updated: 2016-03-30

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-12-31

Brief Summary

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The purpose of this study is to determine whether endurance exercise of either high or moderate intensity can reverse structural and functional changes of the heart in patients with diastolic heart failure, and to investigate which type of exercise is best in terms of aerobe capacity and quality of life.

The investigators expect that high intensity endurance exercise is superior to moderate intensity endurance exercise.

Detailed Description

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This study is a prospective randomized controlled intervention study comparing two active arms. Eligible patients are being sampled consecutively by cardiologists, and randomized to either high or moderate intensity endurance exercise. Endpoints are measured at baseline, 4 weeks and 7 months. The intervention is considered safe, and the study has been approved by the Regional Ethics Committee (REK-midt).

This project has been financially supported by the Norwegian ExtraFoundation for Health and Rehabilitation through EXTRA funds.

Conditions

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Heart Failure, Diastolic Ventricular Dysfunction, Left

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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High intensity endurance exercise

Four weeks comprehensive cardiac rehabilitation with moderate volume high intensity endurance exercise, followed by 6 months non-supervised endurance exercise

Group Type EXPERIMENTAL

High intensity endurance exercise

Intervention Type BEHAVIORAL

Moderate continuous endurance exercise

Four weeks comprehensive cardiac rehabilitation with moderate volume moderate intensity endurance exercise, followed by 6 months non-supervised endurance exercise

Group Type ACTIVE_COMPARATOR

Moderate continuous endurance exercise

Intervention Type BEHAVIORAL

Interventions

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High intensity endurance exercise

Intervention Type BEHAVIORAL

Moderate continuous endurance exercise

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Sedentary lifestyle
* Normal systolic function left ventricular ejection fraction (LVEF) \< 50%
* New York Heart Association (NYHA) class II or III
* Diastolic dysfunction (E/é \< 15 or E/é 8-15 and N-terminal proBNP \> 220pg/ml)
* Medically stable the last 4 weeks
* Written informed consent

Exclusion Criteria

* Other causes of dyspnea than diastolic heart failure
* Personal preferences or characteristics prohibiting the person from attending inpatient cardiac rehabilitation
* Not able to perform physical exercise
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LHL-Klinikkene, Røros

OTHER

Sponsor Role collaborator

LHL-Klinikkene, Feiring

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ulrik Wisløff, phd prof

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Locations

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LHL Klinikkene

Røros, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2014.12327

Identifier Type: -

Identifier Source: org_study_id

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