Pressure-Volume Loop Assessment in Valvular Heart Disease

Not yet recruiting

• Conditions: Heart Failure; Structural Heart Disease; Interventional Cardiology

• Registration Number: NCT07112391
• Lead Sponsor: Nantes University Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-07-25
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-01
• Last Update Submitted: 2025-08-01
• Study First Posted: 2025-08-08
• Last Update Posted: 2025-08-08
• Study Start: 2025-08-15
• Primary Completion: 2025-09-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation with non-invasive echocardiographic parameters	During right heart catheterization (Day 1)	Assessment of diagnostic performances of TAPSE/PAPS, RVFWLS/PAPS and FAC/PAPS ratios compared to Ees/Ea ratio.

Secondary Outcome Measures

Name	Time	Method
Ratios cut-off	During right heart catheterization (Day 1)	Identification of the most performant ratios' values to diagnose RV-PA uncoupling as defined on invasive assessment
Correlation with innovative non-invasive echocardiographic parameters	During right heart catheterization (Day 1)	Diagnostic performance assessment of right ventricular (RV) myocardial work estimated by pressure-strain loop analysis from echocardiography (non-invasive method), compared to RV stroke work measured by pressure-volume loops during right heart catheterization (invasive method). The correlation will be evaluated using Spearman's correlation coefficient.
Correlation with innovative non-invasive parameters derived from multislice imaging	During right heart catheterization (Day 1)	Diagnostic performance assessment of non-invasive RV-PA coupling parameters derived from multislice imaging techniques (magnetic resonance imaging \[MRI\] and/or computed tomography \[CT\]) compared to the Ees/Ea ratio (ventricular end-systolic elastance to arterial elastance), measured invasively using pressure-volume loop analysis during right heart catheterization. The strength of correlation will be evaluated using appropriate statistical methods (e.g., Spearman correlation).
Immediate impact of valvular repair/replacement on RV-PA coupling	During right heart catheterization (Day 1)	Ees/Ea ratio evolution after the intervention.