HFrEF - Heart Failure With Reduced Ejection FractionPrédicRéaNCT07164911
Predictive Factors of Response to Phase II Cardiac Rehabilitation in Heart Failure With Reduced Ejection Fraction
An observational study of HFrEF - Heart Failure With Reduced Ejection Fraction and Cardiac Rehabilitation, run by Centre Hospitalier de Corbie at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- HFrEF - Heart Failure With Reduced Ejection Fraction, Cardiac Rehabilitation, Exercise Training
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 25 Nov 2025to 30 Nov 2027
- How long will I take part?
- 1 Month
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Heart failure patient with altered left ventricular ejection fraction
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hospital center of Corbie
Corbie, 80800
Pierre-Marie Leprêtre, PhD, 33 322 964 120, pierre-marie.lepretre@ch-corbie.fr
Francesco Orlando, MD
About this study
Official title: Prédiction Des réponses du Patient Porteur d'Une Insuffisance Cardiaque à Fraction d'éjection altérée à Une Phase II de réadaptation Cardiaque
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.
Read more
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.
Read the 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:
- Identify which component of the oxygen transport chain is most impaired.
- Combining physiological and molecular assessments could guide tailored rehabilitation strategies.
- Conditions
- HFrEF - Heart Failure With Reduced Ejection Fraction, Cardiac Rehabilitation, Exercise Training, Exercise Adaptations, Exercise Intolerance, Exercise Intervention
- Keywords
- Exercise-based cardiac rehabilitation in patients with reduced left ventricular ejection fraction, VO2peak, MicroRNA, Muscle Oxygenation, arterial stiffness, cardiac output, stroke volume, Oxygen alveolar-arterial gradient, alveolar ventilation, minute ventilation
What is being measured
The primary outcome is the main question the study is designed to answer.
ΔVO₂peak
Variation in peak oxygen consumption during exercise (ΔVO₂peak = postVO₂peak - preVO₂peak), expressed as the percentage change from baseline after exercise training.
Measured: Day 1 : baseline value of peak oxygen consumption (preVO₂peak) Day 21: post value of peak oxygen consumption (post VO₂peak)
circulating microRNAs
Expression of circulating microRNAs (c-miRNAs): miR-146a, miR-191, miR-23a, miR-140, miR-1, miR-21, miR-133a, miR-17-5p, miR-3200-3p
Measured: Day 1 : baseline expression of miRNAs (pre-miRNAs) Day 21: post values of miRNAs expression (post-miRNAs)
Secondary outcomes (7)
Changes in pulmonary ventilation
Changes (pre-post exercise training) in pulmonary ventilation (VE, L·min-¹).
Measured: 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
Changes (pre-post exercise training) in alveolar ventilation (VA, mL·min-¹)
Measured: 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
Changes (pre-post exercise training) in alveolar-arterial oxygen pressure difference (PA-aO₂, mmHg)
Measured: 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
Changes (pre-post exercise training) in cardiac index (CI, L·min-¹·m-²)
Measured: 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
Changes (pre-post exercise training) in arterial stiffness (PWV, m·s-¹)
Measured: 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
Changes (pre-post exercise training) in muscle oxygen saturation (SmO₂, %)
Measured: 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
Changes (pre-post exercise training) in cerebral oxygen saturation (%)
Measured: Day 1: baseline value of cerebral oxygen saturation (%) Day 21: baseline value of cerebral oxygen saturation '%)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start25 Nov 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HFrEF - Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Corbie
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Pierre-Marie Leprêtre, Professor, Study director, Université de Rouen Normandie, UFR-STAPSFrancesco Orlando, MD, Principal investigator, Centre Hospitalier de Corbie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164911
- Sponsor's protocol ID
- Centre hospitalier de Corbie
- Other IDs
- 2025-A01575-44
- Acronym
- PrédicRéa
- Status last verified
- Dec 2025
- First submitted
- 24 Aug 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No