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NCT Number: NCT07112391

Pressure-Volume Loop Assessment in Valvular Heart Disease

The VHD PV loop study intends to assess invasive right ventricular to pulmonary artery (RV-PA) coupling in patients with valvular heart disease (VHD). Invasive RV-PA coupling is measured by using conductance catheters, the gold standard assessment for ventricular physiology. Several non-invasive parameters have been reported as surrogates for this complex physiological entity, but none of them has been tested against the gold-standard in this population. Based on this, our main objective is to assess the correlation of imaging derived RV-PA coupling in comparison to the invasive measurement.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU of NANTES

Nantes, Loire Atlantique, 44000, France

Location status: Recruiting

Location contact

ROBIN LE RUZ, cardiologist, MD

CONTACT

[email protected]

02 53 48 28 35

About this study

This study aims to improve the assessment of right ventricular (RV) function in patients with valvular heart disease (VHD), by validating non-invasive imaging parameters of right ventricular to pulmonary artery (RV-PA) coupling against invasive measurements using conductance catheters-the gold standard for evaluating RV hemodynamics.

Currently available non-invasive tools do not always provide reliable evaluation of RV-PA coupling. This study seeks to identify accurate imaging surrogates to support clinical decision-making, particularly in conditions such as secondary mitral regurgitation, tricuspid regurgitation, and right-sided structural heart disease.

By correlating non-invasive indices-such as tricuspid annular plane systolic excursion to pulmonary artery systolic pressure ratio (TAPSE/PASP) and RV strain-with invasive data, the study may enhance diagnostic strategies, improve patient care, and support future prognostic and therapeutic investigations. Data may also contribute to post hoc analyses in existing registries and help refine our understanding of RV adaptation in structural heart disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational Invasive Hemodynamic Assessment

Other

Collection and analysis of invasive hemodynamic data obtained through routine cardiac catheterization performed as part of standard care. No intervention is mandated by the study protocol.

Other names: Cardiac Catheterization, Hemodynamic Procedure

Primary outcomes

  1. Correlation with non-invasive echocardiographic parameters

    Time frame: During right heart catheterization (Day 1)

    Assessment of diagnostic performances of TAPSE/PAPS, RVFWLS/PAPS and FAC/PAPS ratios compared to Ees/Ea ratio.

Study contacts

Contact information is provided by the study sponsor or research team.

Robin LE RUZ, MD, PhD

CONTACT

[email protected]

02. 53.48.28.36

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • Fédération Française de Cardiologie

Registry information

Official study title

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

Acronym: VHD-PV-loop

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 8, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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