NCT07164911Recruiting
Predictive Factors of Response to Phase II Cardiac Rehabilitation in Heart Failure With Reduced Ejection Fraction
Prédiction Des réponses du Patient Porteur d'Une Insuffisance Cardiaque à Fraction d'éjection altérée à Une Phase II de réadaptation Cardiaque
Source: ClinicalTrials.gov · Last updated 16 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 62 (estimated)
- First submitted
- 24 Aug 2025
- Start date
- 25 Nov 2025
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- Centre Hospitalier de Corbie
- Diseases
- Heart failure, Stroke
- NCT number
- NCT07164911
What you commit to
- Study type: Observational
- Planned participants: 62
- From 25 Nov 2025 to the primary completion date, 31 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Uncontrolled arterial hypertension
- Secondary respiratory disease such as emphysema or chronic obstructive pulmonary disease (COPD)
- Secondary cardiovascular disease
Other
- Contraindication to regular adapted physical activity
- Individuals under legal protection or deprived of liberty
- Pregnant or breastfeeding women
Who the study is looking for
- 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
Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital center of Corbie Coordinator of this site? Confirm its status | Corbie | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.