Exercise Intervention in Patients With Heart Failure With Preserved and Reduced Ejection Fraction

Region Skane

Status: Invitation-only

Conditions: Heart Failure New York Heart Association (NYHA) Class III; Heart Failure New York Heart Association (NYHA) Class II

Treatments: Other: Supervised Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05255172

2021-05044

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Supervised exercise

Experimental group

Description:

The exercise intervention will include 2 supervised sessions of ergometer cycling with a warm up period of 10 minutes and 20 minutes of cycling at the aerobic intensity below the anaerobic threshold as determined from baseline results. Patients in the exercise arm will have 1 unsupervised exercise session where the participants walk or bicycle for 30 minutes at an intensity experienced as somewhat hard (Borg 13) according to the Borg Rating of Perceived Exertion Scale.

Treatment:

Other: Supervised Exercise

Standard of Care

No Intervention group

Description:

The control group will receive advise to continue to live as usual. After 4 and 8 weeks, participants in the control group will be contacted by telephone for inquiry of general wellbeing. No other interventions will be performed in the control group.