Atrial Functional Mitral Regurgitation and Tricuspid Regurgitation

Barts & The London NHS Trust

Status: Enrolling

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

Treatments: Diagnostic Test: Echocardiogram

Study type: Observational

Funder types: Other

Identifiers

NCT05920824

326447

Details and patient eligibility

About

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

Full 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

Enrollment: 141 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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