Clinical trial Recruiting at 1 site Observational Ages 18 and up

Measuring how the right ventricle and pulmonary artery work together in valve disease

Official title: Invasive Hemodynamic Study of Structural Heart Diseases: A Monocentric, Non-Randomized Approach

Run by Nantes University Hospital · NCT07112391 · Data updated 2026-11-12

This project will test whether non-invasive heart imaging can match invasive catheter measurements of right ventricular–pulmonary artery coupling in adults with significant valvular heart disease.

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Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment70 (estimated)
SponsorNantes University Hospital
Academic / other
Locations1 site (Nantes, Loire Atlantique)
StatusRecruiting
StartedSeptember 4, 2025
Main results expectedSeptember 4, 2027
Study endsSeptember 4, 2027
Registry record updatedSeptember 16, 2025
Trial IDNCT07112391 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18 years) with severe structural valvular disease—moderate-to-severe or severe secondary mitral regurgitation, at least severe tricuspid regurgitation, or significant pulmonary valve stenosis/regurgitation—who can safely undergo right-heart catheterization.

Probably not a fit

Patients who are pregnant or breastfeeding, under legal guardianship, or who have contraindications to right-heart catheterization (for example proximal venous occlusion, a mobile right-heart mass, or significant tricuspid stenosis) are unlikely to benefit or be eligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will enroll adults with significant structural valve disease (severe secondary mitral regurgitation, at least severe tricuspid regurgitation, or significant pulmonary valve disease) at CHU Nantes. Participants will undergo invasive right-heart hemodynamic assessment using conductance catheters—the gold standard for RV physiology—alongside standard non-invasive imaging. Researchers will compare invasive RV–PA coupling measures with imaging-derived indices such as TAPSE/PASP and RV strain to quantify correlations. The goal is to identify accurate imaging surrogates that could support clinical decision-making in valvular heart disease.

Why it matters

Potential benefit: If successful, clinicians could rely on validated non-invasive imaging measures to estimate RV–PA coupling, reducing the need for invasive catheterization and improving timing and selection for valve interventions.

How similar studies have gone: Several non-invasive measures like TAPSE/PASP and RV strain have shown promise in other populations, but they have not been directly validated against conductance-catheter measurements in patients with valvular heart disease.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Adult patients (≥ 18 years old);
* Patients with severe structural heart disease (meeting at least one of the following three criteria):

  * Heart failure with moderate-to-severe or severe secondary mitral regurgitation
  * At least severe tricuspid regurgitation
  * Significant pulmonary valve stenosis and/or regurgitation

Exclusion Criteria:

* Patients under legal guardianship or protection (e.g., guardianship, trusteeship, or any other legal protection measure);
* Pregnant or breastfeeding women;
* Vulnerable individuals (e.g., persons deprived of liberty, adults under legal protection);
* Contraindication to right heart catheterization, including:

  * Known proximal venous occlusion of the superior or inferior vena cava territory
  * Presence of a mobile mass in the right heart chambers
  * Significant tricuspid stenosis

Where it's running

  • CHU of NANTES
    Nantes, Loire Atlantique, France
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.