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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 1 site (Nantes, Loire Atlantique) |
| Status | Recruiting |
| Started | September 4, 2025 |
| Main results expected | September 4, 2027 |
| Study ends | September 4, 2027 |
| Registry record updated | September 16, 2025 |
| Trial ID | NCT07112391 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
- Principal investigator: Robin LE RUZ, MD, PhD — Hospital of Nantes
- Study coordinator: Robin LE RUZ, MD, PhD
- Email: robin.leruz@chu-nantes.fr
- Phone: 02. 53.48.28.36
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Using Apple Watch data to predict heart failure outcomes
This study is testing if data from Apple Watches can help predict heart failure problems and the chances of needing to go back to the hospital for patients with heart failure.
-
Comparing Aortix Device to Diuretics for Acute Heart Failure
This study is testing whether the Aortix device can help people with acute heart failure who aren't responding to diuretics feel better compared to standard treatment.
-
Myocardial Energetics Across Cardiovascular Disease Spectrum Using 31P-MRS
Researchers are testing whether phosphorus-31 magnetic resonance spectroscopy (31P-MRS) can map heart energy metabolism across healthy people and patients with various heart conditions.
-
Tailored digital support to cut sedentary time in long-term cardiac rehab
In adults in a long-term cardiac rehabilitation program, this study tests whether a personalized behavioural program with digital tools can reduce daily sitting time.
-
NT-proBNP–guided heart failure screening for people 65+ in rural China
This study tests whether using NT-proBNP blood tests to guide heart failure screening in adults 65 and older in rural China can find unrecognized heart problems more effectively than symptom-based screening.
-
Voice-based detection of heart failure deterioration using Noah Labs Vox
This study tests whether a voice-analysis app can flag worsening heart failure in adults by comparing its alerts to standard weight-based monitoring.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.