Atrial Functional Mitral Regurgitation and Tricuspid Regurgitation

Recruiting

• Conditions: Functional Tricuspid Regurgitation; Functional Mitral Regurgitation; Atrial Fibrillation

• Registration Number: NCT05920824
• Lead Sponsor: Barts & The London NHS Trust

Brief 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

Study Timeline

• Study First Submitted: 2023-06-16
• Study First Submitted QC: 2023-06-16
• Study First Posted: 2023-06-27
• Study Start: 2023-12-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-04
• Primary Completion: 2026-09
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 141

Inclusion Criteria

• Informed consent
• Age of 18 years or older
• Atrial fibrillation
• Moderate or severe atrial valve disease
• Adequate 2D echocardiography views including parasternal long axis, short axis, apical two chamber, apical three chamber and four chamber.

Exclusion Criteria

• Unwilling or unable to give consent
• Left ventricular impairment (ejection fraction < 50%).
• Primary/organic valve disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effective Regurgitant Orifice Area at 1 year	1 year	Measure the EROA by echocardiography after 1 year

Secondary Outcome Measures

Name	Time	Method
Heart Failure admission within 1 year of recruitment.	1 year	incidence of heart failure admissions within a one-year period following the recruitment of participants.
Mortality	1 year	Document and analyze the mortality rates among participants
Functional: New York Heart Association Class, Predicted VO2max (<84%).	1 year	Evaluate participants' physical abilities and endurance, focusing on two key measures: The New York Heart Association (NYHA) Functional Classification and the predicted maximum oxygen uptake (VO2max)
Progression of valve disease defined as worsening of mitral or tricuspid regurgitation > 1 grade at 1 year.	1 year	Measure the change in regurgitation severity

Trial Locations

Locations (1)

St Bartholomew's Hospital; 🇬🇧 London, United Kingdom