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Clinical Trials/NCT02155842
NCT02155842
Withdrawn
Not Applicable

High Versus Moderate Intensity Endurance Exercise Training in Treating Diastolic Heart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure, Diastolic
Sponsor
Norwegian University of Science and Technology
Locations
1
Primary Endpoint
Change in aerobic capacity measured as oxygen consumption
Status
Withdrawn
Last Updated
10 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
June 2014
End Date
December 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in aerobic capacity measured as oxygen consumption

Time Frame: Baseline and 7 months

Cardiopulmonary exercise test

Secondary Outcomes

  • Changes in everyday activity level(Baseline to 7 months)
  • Change in diastolic filling pressure measured as E/é(Baseline to 7 months)
  • Arterial function measured as blood-vessel elasticity(Baseline to 7 months)
  • Cardiac function measured as volume, size, efficacy(Baseline to 7 months)
  • Quality of life(Baseline to 7 months)
  • Feasibility, measured as attrition rate and compliance with exercise(Baseline to 7 months)
  • Blood-risk profile, measured as changes in cholesterol, hemoglobin, N terminal-proBNP(Baseline to 7 months)

Study Sites (1)

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