Predictive Factors of Response to Phase II Cardiac Rehabilitation in Heart Failure With Reduced Ejection Fraction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: HFrEF - Heart Failure With Reduced Ejection Fraction, Cardiac Rehabilitation, Exercise Training, Exercise Adaptations. Basic parameters: 40 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prédiction Des réponses du Patient Porteur d'Une Insuffisance Cardiaque à Fraction d'éjection altérée à Une Phase II de réadaptation Cardiaque
Overview
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.
Detailed description
Key Takeaways VO₂peak is a clinically relevant, prognostic measure in HFrEF. .ExCR benefits are heterogeneous, partly due to variable cardiac and muscular adaptations. c-miRNAs may mediate or indicate the molecular response to ExCR. c-miRNAs may Enhance pulmonary, cardiac, or muscular adaptations → improved VO₂peak, or, if maladaptive, contribute to fatigue → explaining non-response.
Goal Connect ΔVO₂peak with cellular precursors of adaptation, providing a mechanistic understanding of CR responses.
Method 62 patients with HFrEF will be engaged in a this prospective, single-center cohort follow-up study with a prognostic aim and minimal risk to human participants.
Peak values of oxygen uptake, cardiac hemodynamics, cerebral and muscle oxygenation, non-coding RNA will be measured before and after Exercise based cardiac rehabilitation during a cardiopulmonary exercise testing. All the patients will perform a force - velocity test in order to prescribe an individualized resistance training program.
Originality of study: Combines non-invasive physiological measurements during exercise and biomarker (c-miRNA) analysis before and after ExCR.
Scientific and Clinical Significance
Linking non-invasive measurements and epigenetic markers could:
1. Identify which component of the oxygen transport chain is most impaired. 2. Combining physiological and molecular assessments could guide tailored rehabilitation strategies.
Primary outcome measures
- ΔVO₂peak [Time frame: Day 1 : baseline value of peak oxygen consumption (preVO₂peak) Day 21: post value of peak oxygen consumption (post VO₂peak)]
- circulating microRNAs [Time frame: Day 1 : baseline expression of miRNAs (pre-miRNAs) Day 21: post values of miRNAs expression (post-miRNAs)]
Secondary outcome measures (7)
- Changes in pulmonary ventilation [Time frame: Day 1: pulmonary ventilation at baseline (preVE, L·min-¹) Day 21: post value of pulmonary ventilation (postVE, L·min-¹)]
- Changes in alveolar ventilation with exercise training [Time frame: Day 1: alveolar ventilation at baseline (postVA, mL·min-¹) Day 21: post value of alveolar ventilation (postVA, mL·min-¹)]
- Changes in alveolar-arterial oxygen pressure difference with exercise training [Time frame: Day 1: baseline alveolar-arterial oxygen pressure difference value (prePA-aO₂, mmHg) Day 21: post value of alveolar-arterial oxygen pressure difference (postPA-aO₂, mmHg)]
- Changes in cardiac index with exercise training [Time frame: Day 1: baseline value of cardiac index (preCI, L·min-¹·m-²) Day 21: post value of cardiac index (postCI, L·min-¹·m-²)]
- Changes in arterial stiffness with exercise training [Time frame: Day 1: baseline value of arterial stiffness (prePWV, m·s-¹) Day 21: post value of arterial stiffness (postPWV, m·s-¹)]
- Changes in muscle oxygen saturation [Time frame: Day 1: baseline value of muscle oxygen saturation (preSmO₂, %) Day 2: post value of muscle oxygen saturation (postSmO₂, %)]
- Changes in cerebral oxygen saturation with exercise training [Time frame: Day 1: baseline value of cerebral oxygen saturation (%) Day 21: baseline value of cerebral oxygen saturation '%)]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hospital center of Corbie — Corbie
Identifiers
NCT: NCT07164911 · Centre hospitalier de Corbie · 2025-A01575-44