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

Not Applicable

• Conditions: Heart Failure New York Heart Association (NYHA) Class III; Heart Failure New York Heart Association (NYHA) Class II
• Interventions: Other: Supervised Exercise

• Registration Number: NCT05255172
• Lead Sponsor: Region Skane

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 Timeline

• Study First Submitted: 2022-01-20
• Study First Submitted QC: 2022-02-15
• Study First Posted: 2022-02-24
• Study Start: 2022-06-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 120

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supervised exercise	Supervised Exercise	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.

Primary Outcome Measures

Name	Time	Method
Maximal oxygen uptake (VO2peak)	12 weeks intervention	a change in maximal oxygen uptake (VO2 peak) of 2 ml/min/kg

Secondary Outcome Measures

Name	Time	Method
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
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
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.

Trial Locations

Locations (1)

Skåne University Hospital Lund; 🇸🇪 Lund, Sweden