Predicting who improves after phase II cardiac rehabilitation for 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
This project will test whether blood microRNA patterns together with non-invasive exercise measurements can predict which people with reduced ejection fraction heart failure will improve their peak oxygen uptake after a phase II cardiac rehab program.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 62 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Centre Hospitalier de Corbie Government |
| Locations | 1 site (Corbie) |
| Trial ID | NCT07164911 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-center cohort of 62 patients with heart failure with reduced ejection fraction (LVEF <40%) who will complete a phase II exercise-based cardiac rehabilitation program. Researchers will measure peak oxygen uptake (VO2peak), cardiac hemodynamics, cerebral and muscle oxygenation during cardiopulmonary exercise testing, and circulating microRNA levels before and after the program. Participants will also perform a force–velocity test to guide individualized resistance training. The study links physiological exercise responses to molecular markers to identify predictors of improvement in ΔVO2peak.
Who should consider this trial
Good fit: Adults with HFrEF (LVEF <40%), NYHA class II or higher, clinically stable and on optimized medical therapy for at least 6 weeks, prescribed phase II cardiac rehabilitation, BMI 20–30 kg/m², sedentary or untrained, able to give informed consent and affiliated with the French national health insurance system.
Not a fit: Patients with contraindications to adapted physical activity, uncontrolled hypertension, significant secondary respiratory or cardiovascular disease, those outside the BMI or stability criteria, pregnant or breastfeeding individuals, or those unable to attend the center are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help personalize cardiac rehabilitation so clinicians can target the component(s) of oxygen delivery or utilization most likely to improve each patient’s exercise capacity.
How similar studies have performed: Exercise-based cardiac rehabilitation is known to improve VO2peak for many patients with HFrEF, but using circulating microRNAs to predict individual responses is a relatively novel approach that is not yet established.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Corbie
- Hospital center of Corbie — Corbie, France (Recruiting)
Study contacts
- Principal investigator: Francesco Orlando, MD — Centre Hospitalier de Corbie
- Study coordinator: Pierre-Marie Leprêtre, professor
- Email: pierre-marie.lepretre@univ-rouen.fr
- Phone: +33235148113
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.