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

Primary Purpose

Heart Failure, Diastolic, Ventricular Dysfunction, Left

Status
Withdrawn
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
High intensity endurance exercise
Moderate continuous endurance exercise
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Diastolic focused on measuring exercise therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • LHL Klinikkene

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High intensity endurance exercise

Moderate continuous endurance exercise

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in aerobic capacity measured as oxygen consumption
Cardiopulmonary exercise test

Secondary Outcome Measures

Feasibility, measured as attrition rate and compliance with exercise
Blood-risk profile, measured as changes in cholesterol, hemoglobin, N terminal-proBNP
Cardiac function measured as volume, size, efficacy
Ultrasound
Arterial function measured as blood-vessel elasticity
Ultrasound
Quality of life
Self-reported questionnaires
Changes in everyday activity level
Self-reported questionnaire, diary, activity monitoring device
Change in diastolic filling pressure measured as E/é
Ultrasound

Full Information

First Posted
May 27, 2014
Last Updated
March 29, 2016
Sponsor
Norwegian University of Science and Technology
Collaborators
LHL-Klinikkene, Røros, LHL-Klinikkene, Feiring
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1. Study Identification

Unique Protocol Identification Number
NCT02155842
Brief Title
Exercise Training in Treating Diastolic Heart Failure
Acronym
TREND-HF
Official Title
High Versus Moderate Intensity Endurance Exercise Training in Treating Diastolic Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Unforseen problems recruiting patients
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
LHL-Klinikkene, Røros, LHL-Klinikkene, Feiring

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Diastolic, Ventricular Dysfunction, Left
Keywords
exercise therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High intensity endurance exercise
Arm Type
Experimental
Arm Description
Four weeks comprehensive cardiac rehabilitation with moderate volume high intensity endurance exercise, followed by 6 months non-supervised endurance exercise
Arm Title
Moderate continuous endurance exercise
Arm Type
Active Comparator
Arm Description
Four weeks comprehensive cardiac rehabilitation with moderate volume moderate intensity endurance exercise, followed by 6 months non-supervised endurance exercise
Intervention Type
Behavioral
Intervention Name(s)
High intensity endurance exercise
Intervention Type
Behavioral
Intervention Name(s)
Moderate continuous endurance exercise
Primary Outcome Measure Information:
Title
Change in aerobic capacity measured as oxygen consumption
Description
Cardiopulmonary exercise test
Time Frame
Baseline and 7 months
Secondary Outcome Measure Information:
Title
Feasibility, measured as attrition rate and compliance with exercise
Time Frame
Baseline to 7 months
Title
Blood-risk profile, measured as changes in cholesterol, hemoglobin, N terminal-proBNP
Time Frame
Baseline to 7 months
Title
Cardiac function measured as volume, size, efficacy
Description
Ultrasound
Time Frame
Baseline to 7 months
Title
Arterial function measured as blood-vessel elasticity
Description
Ultrasound
Time Frame
Baseline to 7 months
Title
Quality of life
Description
Self-reported questionnaires
Time Frame
Baseline to 7 months
Title
Changes in everyday activity level
Description
Self-reported questionnaire, diary, activity monitoring device
Time Frame
Baseline to 7 months
Title
Change in diastolic filling pressure measured as E/é
Description
Ultrasound
Time Frame
Baseline to 7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrik Wisløff, phd prof
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
LHL Klinikkene
City
Røros
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

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Exercise Training in Treating Diastolic Heart Failure

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