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OpenTrials
Enrolling by Invitation

NCT Number: NCT05255172

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

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.

Enrolling by Invitation

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Key information

Conditions

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

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Skåne University Hospital Lund

Lund, 22158, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supervised Exercise

Other

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

Primary outcomes

  1. Maximal oxygen uptake (VO2peak)

    Time frame: 12 weeks intervention

    a change in maximal oxygen uptake (VO2 peak) of 2 ml/min/kg

Secondary outcomes

  1. Health related quality of life

    Time frame: 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.

  2. Cardiac volumes and function

    Time frame: 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

  3. Perfusion gradients on Ventilation / Perfusion Single Photon Emission Computed Tomography (V/P SPECT)

    Time frame: 12 weeks intervention

    Change in pulmonary congestion quantified by V/P SPECT

  4. Mitochondrial function

    Time frame: 12 weeks intervention

    Change in mitochondrial number and function using respirometry indicating effects of the exercise intervention as compared to the control group

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

Physiological Mechanisms Affecting Exercise Capacity in Patients With Heart Failure - an Exercise Intervention Study Evaluated With Several Modalities

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Feb 24, 2022
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.