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

N/AEnrolling By InvitationNCT05255172

Region Skane120 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Heart Failure New York Heart Association (NYHA) Class II Heart Failure New York Heart Association (NYHA) Class III

Interventions

Supervised ExerciseOTHER

12 weeks of supervised aerobic exercise individually adapted to exercise capacity according to a VO2 peak test

Eligibility

Sex: ALLMin age: 50 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Skåne University Hospital Lund

Lund, Sweden