NCT05920824

Atrial Functional Mitral Regurgitation and Tricuspid Regurgitation

Clinical Phenotypes, Risk Factors, & Determinants of Outcome in Functional Mitral and Tricuspid Valve Regurgitation

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 141 (estimated)
• Sponsor: Barts & The London NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, observational cohort study designed to identify clinical phenotypes and evaluate predictors \& outcomes of functional mitral and tricuspid valve regurgitation in patients with atrial fibrillation. Participant will under go: * Baseline echocardiography * Cpex Echocardiography * Blood test: BNP * 1 year follow up Echocardiography Participants will be stratified into three subgroups: * Atrial Functional MR * Atrial Functional TR * Mixed MR \& TR

Detailed description

Rationale The natural history and risk factors for atrial valve disease are poorly understood and characterised. This study will examine differences between atrial mitral and atrial tricuspid disease and help us understand the natural history of these pathologies. Study objectives Primary objective * Identify \& characterise phenotypes in functional mitral and tricuspid valve regurgitation * Identify risk factors for progression of disease and outcome. Secondary objective Compare the three groups: atrial functional MR, atrial functional TR, and mixed disease, and identify any differences/similarities. Primary endpoint Effective Regurgitant Orifice Area at 1 year Secondary endpoint * Progression of valve disease defined as worsening of mitral or tricuspid regurgitation \> 1 grade at 1 year. * Functional: New York Heart Association Class, Predicted VO2max (\<84%). * Heart Failure admission within 1 year of recruitment. * Mortality. Recruitment will take place from the out-patient clinics \& echocardiography laboratory at St Bartholomew's Hospital

Conditions

• Atrial Fibrillation
• Functional Mitral Regurgitation
• Functional Tricuspid Regurgitation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Echocardiogram	Ultrasound scan of the heart

Timeline

• Start date: 2023-12-01
• Primary completion: 2026-09-01
• Completion: 2027-02-01
• First posted: 2023-06-27
• Last updated: 2025-03-04

Locations

1 site across 1 country: United Kingdom