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
- Are there results?
- Not yet: the study is under way
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
Show all 9Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prédiction Des réponses du Patient Porteur d'Une Insuffisance Cardiaque à Fraction d'éjection altérée à Une Phase II de réadaptation Cardiaque
- ClinicalTrials.gov ID
- NCT07164911
- Acronym / sponsor ID
- PrédicRéa / Centre hospitalier de Corbie
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Centre Hospitalier de CorbieOther government
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Identify which component of the oxygen transport chain is most impaired.
- Combining physiological and molecular assessments could guide tailored rehabilitation strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart failure patient with altered left ventricular ejection fraction
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ΔVO₂peak
Time frame: Day 1 : baseline value of peak oxygen consumption (preVO₂peak) Day 21: post value of peak oxygen consumption (post VO₂peak)
Variation in peak oxygen consumption during exercise (ΔVO₂peak = postVO₂peak - preVO₂peak), expressed as the percentage change from baseline after exercise training.
circulating microRNAs
Time frame: Day 1 : baseline expression of miRNAs (pre-miRNAs) Day 21: post values of miRNAs expression (post-miRNAs)
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
7 secondary outcomes
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 '%)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pierre-Marie Leprêtre, Professor study director
Université de Rouen Normandie, UFR-STAPS
Francesco Orlando, MD principal investigator
Centre Hospitalier de Corbie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre-Marie Leprêtre, professor (+33235148113, pierre-marie.lepretre@univ-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ΔVO₂peak (time frame: Day 1 : baseline value of peak oxygen consumption (preVO₂peak) Day 21: post value of peak oxygen consumption (post VO₂peak)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.