Predictive Factors of Response to Phase II Cardiac Rehabilitation in Heart Failure With Reduced Ejection Fraction

NCT07164911 | Recruiting

• 2 other identifiers: Centre hospitalier de Corbie2025-A01575-44
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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). 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.

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

Outcome Measures

Primary Outcomes (2)

• ΔVO₂peak

  Variation in peak oxygen consumption during exercise (ΔVO₂peak = postVO₂peak - preVO₂peak), expressed as the percentage change from baseline after exercise training.

  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

  Day 1 : baseline expression of miRNAs (pre-miRNAs) Day 21: post values of miRNAs expression (post-miRNAs)

Secondary Outcomes (7)

• Changes in pulmonary ventilation

  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

  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

  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

  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

  Day 1: baseline value of arterial stiffness (prePWV, m·s-¹) Day 21: post value of arterial stiffness (postPWV, m·s-¹)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Heart failure patient with altered left ventricular ejection fraction

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier de Corbie: lead

Study Sites (1)

Hospital center of Corbie

Corbie, 80800, France

RECRUITING

Study Officials

• Pierre-Marie Leprêtre, Professor

  Université de Rouen Normandie, UFR-STAPS

  STUDY DIRECTOR

• Francesco Orlando, MD

  Centre Hospitalier de Corbie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre-Marie Leprêtre, professor

CONTACT

+33235148113; pierre-marie.lepretre@univ-rouen.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: September 10, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

FR (1)