Exercise Training in Treating Diastolic Heart Failure (TREND-HF)

Norwegian University of Science and Technology

Status: Withdrawn

Conditions: Ventricular Dysfunction, Left; Heart Failure, Diastolic

Treatments: Behavioral: High intensity endurance exercise; Behavioral: Moderate continuous endurance exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT02155842

2014.12327

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

High intensity endurance exercise

Experimental group

Description:

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

Treatment:

Behavioral: High intensity endurance exercise

Moderate continuous endurance exercise

Active Comparator group

Description:

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

Treatment:

Behavioral: Moderate continuous endurance exercise