Exercise Training in Treating Diastolic Heart Failure

Heart Failure, Diastolic Clinical Trial

— TREND-HF  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02155842
• Other study ID #: 2014.12327
• Status: Withdrawn
• Phase: N/A
• First received: May 27, 2014
• Last updated: March 29, 2016
• Start date: June 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Diastolic
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Behavioral:
• High intensity endurance exercise

• Moderate continuous endurance exercise

Locations

Country	Name	City	State
Norway	LHL Klinikkene	Røros

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	LHL-Klinikkene, Feiring, LHL-Klinikkene, Røros

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in aerobic capacity measured as oxygen consumption	Cardiopulmonary exercise test	Baseline and 7 months	No
Secondary	Feasibility, measured as attrition rate and compliance with exercise		Baseline to 7 months	No
Secondary	Blood-risk profile, measured as changes in cholesterol, hemoglobin, N terminal-proBNP		Baseline to 7 months	No
Secondary	Cardiac function measured as volume, size, efficacy	Ultrasound	Baseline to 7 months	No
Secondary	Arterial function measured as blood-vessel elasticity	Ultrasound	Baseline to 7 months	No
Secondary	Quality of life	Self-reported questionnaires	Baseline to 7 months	No
Secondary	Changes in everyday activity level	Self-reported questionnaire, diary, activity monitoring device	Baseline to 7 months	No
Secondary	Change in diastolic filling pressure measured as E/é	Ultrasound	Baseline to 7 months	No