Predictive Factors of Response to Phase II Cardiac Rehabilitation in Heart Failure With Reduced Ejection Fraction

Recruiting now

Conditions studied: HFrEF - Heart Failure With Reduced Ejection Fraction, Cardiac Rehabilitation, Exercise Training, Exercise Adaptations, Exercise Intolerance, Exercise Intervention

In brief

Exercise intolerance, measured as peak oxygen consumption (VO₂peak) during exercise in patients with heart failure with reduced ejection fraction (HFrEF). Change in VO₂peak (ΔVO₂peak), which serves as a prognostic marker for HFrEF engaged in exercise based cardiac rehabilitation program (ExCR). Responders to ExCR generally show improved cardiac function but some patients with HFrEF do not respond to ExCR. VO₂peak depends on three major components of oxygen transport: Pulmonary (lungs), circulatory (heart and vessels) and skeletal muscle (oxygen utilization) functions. These physiological responses to ExCR may be influenced by epigenetic regulation, specifically the expression of circulating microRNAs (c-miRNAs). Linking non-invasive measurements and epigenetic markers could 1) identify which component of the oxygen transport chain is most impaired and 2) allow personalized interventions to maximize VO₂peak improvements. The primary objective of this stidy is to assess the association between changes in VO₂peak during exercise training and circulating microRNA expression (miR-146a, miR-191, miR-23a, miR-140, miR-1, miR-21, miR-133a, miR-17-5p, miR-3200-3p). The secondary objective is to examine the relationship between pulmonary, cardiovascular, and neuromuscular adaptations to exercise and circulating microRNA expression.

Key facts

Study ID

NCT07164911

Run by

Centre Hospitalier de Corbie

People needed

62

Starts

2025-11-25

Expected to finish

2027-11-30

Last updated by the study team

2025-12-16

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Heart failure with reduced ejection fraction < 40%
• NYHA functional class ≥ II
• Clinically stable for at least 6 weeks
• On optimized medical therapy for at least 6 weeks
• Prescription for phase II cardiac rehabilitation
• BMI between 20-30 kg·m-²
• Physical activity level: sedentary or physically active but untrained
• Signed informed consent to participate in the study
• Affiliation to the French national health insurance system

You may not qualify if…

• Contraindication to regular adapted physical activity
• Uncontrolled arterial hypertension
• Secondary respiratory disease such as emphysema or chronic obstructive pulmonary disease (COPD)
• Secondary cardiovascular disease
• Individuals under legal protection or deprived of liberty
• Pregnant or breastfeeding women

Where it is running

• Hospital center of Corbie — Corbie, France (enrolling)

Full record on ClinicalTrials.gov

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