Clinical trial NCT02155842: Exercise Training in Treating Diastolic Heart Failure
Official title: High Versus Moderate Intensity Endurance Exercise Training in Treating Diastolic Heart Failure
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Heart Failure, Diastolic
Ventricular Dysfunction, Left
Keywords: exercise therapy
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: LHL-Klinikkene, Røros
name: LHL-Klinikkene, Feiring
First posted: 2014-06-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in aerobic capacity measured as oxygen consumption
timeFrame: Baseline and 7 months
Secondary outcomes:
measure: Feasibility, measured as attrition rate and compliance with exercise
timeFrame: Baseline to 7 months
measure: Blood-risk profile, measured as changes in cholesterol, hemoglobin, N terminal-proBNP
timeFrame: Baseline to 7 months
measure: Cardiac function measured as volume, size, efficacy
timeFrame: Baseline to 7 months
measure: Arterial function measured as blood-vessel elasticity
timeFrame: Baseline to 7 months
measure: Quality of life
timeFrame: Baseline to 7 months
measure: Changes in everyday activity level
timeFrame: Baseline to 7 months
measure: Change in diastolic filling pressure measured as E/é
timeFrame: Baseline to 7 months
Other outcomes:
Locations:
city: Røros
country: Norway
facility: LHL Klinikkene
Study officials:
affiliation: Norwegian University of Science and Technology
name: Ulrik Wisløff, phd prof
role: STUDY_DIRECTOR
References: