Exercise Training in Treating Diastolic Heart Failure

NCT02155842 | Withdrawn

• 1 other identifier: 2014.12327
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure, Diastolic; Ventricular Dysfunction, Left

Keywords

exercise therapy

Outcome Measures

Primary Outcomes (1)

• Change in aerobic capacity measured as oxygen consumption

  Cardiopulmonary exercise test

  Baseline and 7 months

Secondary Outcomes (7)

• 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

• Cardiac function measured as volume, size, efficacy

  Baseline to 7 months

• Arterial function measured as blood-vessel elasticity

  Baseline to 7 months

• Quality of life

  Baseline to 7 months

Study Arms (2)

High intensity endurance exercise

EXPERIMENTAL

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

Behavioral: High intensity endurance exercise

Moderate continuous endurance exercise

ACTIVE COMPARATOR

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

Behavioral: Moderate continuous endurance exercise

Interventions

High intensity endurance exercise BEHAVIORAL

High intensity endurance exercise

Moderate continuous endurance exercise BEHAVIORAL

Moderate continuous endurance exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• LHL-Klinikkene, Røros: collaborator
• LHL-Klinikkene, Feiring: collaborator

Study Sites (1)

LHL Klinikkene

Røros, Norway

Location

MeSH Terms

Conditions

Heart Failure, Diastolic; Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction

Study Officials

• Ulrik Wisløff, phd prof

  Norwegian University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: June 4, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 30, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)