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Clinical Trials in France / NCT07164911
Recruiting Observational

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

NCT07164911 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier de Corbie
Phase
Observational
Started
2025-11-25
Last updated
2025-12-16

Condition(s) studied

HFrEF - Heart Failure With Reduced Ejection FractionCardiac RehabilitationExercise TrainingExercise AdaptationsExercise IntoleranceExercise Intervention

Study summary

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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hospital center of Corbie Corbie France Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07164911 on ClinicalTrials.gov ↗ ← All trials in France