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

NCT07164911 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 62

Last updated 2025-12-16

No results posted yet for this study

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

Sponsors & Collaborators

  • Centre Hospitalier de Corbie

    lead OTHER_GOV

Principal Investigators

  • Pierre-Marie Leprêtre, Professor · Université de Rouen Normandie, UFR-STAPS

  • Francesco Orlando, MD · Centre Hospitalier de Corbie

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-25
Primary Completion
2027-10-31
Completion
2027-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07164911 on ClinicalTrials.gov