- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02155842
Exercise Training in Treating Diastolic Heart Failure (TREND-HF)
High Versus Moderate Intensity Endurance Exercise Training in Treating Diastolic Heart Failure
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Røros, Norway
- LHL Klinikkene
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High intensity endurance exercise
Four weeks comprehensive cardiac rehabilitation with moderate volume high intensity endurance exercise, followed by 6 months non-supervised endurance exercise
|
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Active Comparator: Moderate continuous endurance exercise
Four weeks comprehensive cardiac rehabilitation with moderate volume moderate intensity endurance exercise, followed by 6 months non-supervised endurance exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in aerobic capacity measured as oxygen consumption
Time Frame: Baseline and 7 months
|
Cardiopulmonary exercise test
|
Baseline and 7 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility, measured as attrition rate and compliance with exercise
Time Frame: Baseline to 7 months
|
Baseline to 7 months
|
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Blood-risk profile, measured as changes in cholesterol, hemoglobin, N terminal-proBNP
Time Frame: Baseline to 7 months
|
Baseline to 7 months
|
|
Cardiac function measured as volume, size, efficacy
Time Frame: Baseline to 7 months
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Ultrasound
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Baseline to 7 months
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Arterial function measured as blood-vessel elasticity
Time Frame: Baseline to 7 months
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Ultrasound
|
Baseline to 7 months
|
Quality of life
Time Frame: Baseline to 7 months
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Self-reported questionnaires
|
Baseline to 7 months
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Changes in everyday activity level
Time Frame: Baseline to 7 months
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Self-reported questionnaire, diary, activity monitoring device
|
Baseline to 7 months
|
Change in diastolic filling pressure measured as E/é
Time Frame: Baseline to 7 months
|
Ultrasound
|
Baseline to 7 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014.12327
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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