Actively Recruiting

Age: 40Years - 75Years
All Genders
NCT07164911

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

Led by Centre Hospitalier de Corbie · Updated on 2025-12-16

62

Participants Needed

1

Research Sites

105 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 40Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Heart failure with reduced ejection fraction < 40%
  • New York Heart Association (NYHA) functional class II or higher
  • Clinically stable for at least 6 weeks
  • On optimized medical therapy for at least 6 weeks
  • Prescription for phase II cardiac rehabilitation
  • Body mass index (BMI) between 20 and 30 kg/m²
  • Sedentary or physically active but untrained
  • Signed informed consent to participate in the study
  • Affiliated with the French national health insurance system
Not Eligible

You will not qualify if you...

  • Contraindication to regular adapted physical activity
  • Uncontrolled arterial hypertension
  • Secondary respiratory diseases such as emphysema or chronic obstructive pulmonary disease (COPD)
  • Secondary cardiovascular disease
  • Individuals under legal protection or deprived of liberty
  • Pregnant or breastfeeding women

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hospital center of Corbie

Corbie, France, 80800

Actively Recruiting

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Research Team

P

Pierre-Marie Leprêtre, professor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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