Physiological Mechanisms Affecting Exercise Capacity in Patients With Heart Failure - an Exercise Intervention Study Evaluated With Several Modalities
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Region Skane
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Maximal oxygen uptake (VO2peak)
Study Overview
Brief Summary
The objective of this study is to assess by what physiological mechanisms patients with heart failure benefit from exercise. Effects of an exercise intervention will be assessed for both central (heart and lungs) and peripheral (muscle fiber and mitochondria) factors.
Detailed Description
A randomized, non-blinded prospective intervention trial. Patients randomized to exercise intervention will undergo supervised aerobic training on ergometer cycle for 12 weeks whilst control group receives standard care. Before and after the intervention, all participants will undergo cardiac magnetic resonance imaging (cardiac MR) examinations, Ventilation/Perfusion Single Photon Emission Computed Tomography (V/P SPECT), Cardiopulmonary exercise tests, muscle biopsies and blood sampling.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Signs and symptoms of heart failure
- •Age ≥50 years
- •Stable chronic heart failure (no hospitalizations within past month, no new medications past month)
- •Able to understand and follow exercise prescription
- •Currently physically inactive (less than 150 minutes/week moderate intensity exercise)
- •Exclusion criteria:
- •Currently or within the past 6 months been involved in cardiac rehab with exercise
- •Devices or implants not compatible with magnetic resonance imaging or exercise testing
- •Any orthopedic or medical condition affecting participation in testing and training
- •Signs of acute ischemia during baseline cardiopulmonary exercise testing
- •Participation in other clinical trials that may affect results
- •Moderate or severe valvular disease
- •Atrial fibrillation
- •Moderate or severe chronic obstructive pulmonary disease
- •NYHA class IV
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Maximal oxygen uptake (VO2peak)
Time Frame: 12 weeks intervention
a change in maximal oxygen uptake (VO2 peak) of 2 ml/min/kg
Secondary Outcomes
- Health related quality of life(12 weeks intervention)
- Perfusion gradients on Ventilation / Perfusion Single Photon Emission Computed Tomography (V/P SPECT)(12 weeks intervention)
- Mitochondrial function(12 weeks intervention)
- Cardiac volumes and function(12 weeks intervention)