Pressure-Volume Loop Assessment in Valvular Heart Disease

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Observational Invasive Hemodynamic Assessment
  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.

Первичные конечные точки

• Correlation with non-invasive echocardiographic parameters [Срок оценки: During right heart catheterization (Day 1)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• CHU of NANTES — Nantes

Идентификаторы

NCT: NCT07112391 · RC25_0116

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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