Heart Failure New York Heart Association (NYHA) Class II, Heart Failure New York Heart Association (NYHA) Class III
Conditions
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.
Interventions
OTHERSupervised Exercise
12 weeks of supervised aerobic exercise individually adapted to exercise capacity according to a VO2 peak test
Sponsors
Region Skane
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Signs and symptoms of heart failure 2. Age ≥50 years 3. Stable chronic heart failure (no hospitalizations within past month, no new medications past month) 4. Able to understand and follow exercise prescription 5. Currently physically inactive (less than 150 minutes/week moderate intensity exercise)
Exclusion criteria
1. Currently or within the past 6 months been involved in cardiac rehab with exercise 2. Devices or implants not compatible with magnetic resonance imaging or exercise testing 3. Any orthopedic or medical condition affecting participation in testing and training 4. Signs of acute ischemia during baseline cardiopulmonary exercise testing 5. Participation in other clinical trials that may affect results 6. Moderate or severe valvular disease 7. Atrial fibrillation 8. Moderate or severe chronic obstructive pulmonary disease 9. NYHA class IV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximal oxygen uptake (VO2peak) | 12 weeks intervention | a change in maximal oxygen uptake (VO2 peak) of 2 ml/min/kg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health related quality of life | 12 weeks intervention | Change in Health related quality of life assessed with Kansas City Cardiomyopathy Questionnaire (KCCQ). KCCQ scores are scaled from 0 to 100 and summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent. |
| Cardiac volumes and function | 12 weeks intervention | Change in cardiac volumes and function assessed using Cardiac MR indicating effects of the exercise intervention as compared to the control group |
| Perfusion gradients on Ventilation / Perfusion Single Photon Emission Computed Tomography (V/P SPECT) | 12 weeks intervention | Change in pulmonary congestion quantified by V/P SPECT |
| Mitochondrial function | 12 weeks intervention | Change in mitochondrial number and function using respirometry indicating effects of the exercise intervention as compared to the control group |
Countries
Sweden
Outcome results
None listed