Atrial Functional Mitral Regurgitation and Tricuspid Regurgitation

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

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

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Functional Mitral Regurgitation; Functional Tricuspid Regurgitation
• Intervention / Treatment: Diagnostic test: Echocardiogram

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 Type: Observational
• Enrollment (Estimated): 141

Contacts and Locations

• Study Contact: Name: Jawza Aldakhil; Phone Number: 00447899770693; Email: Jawza@outlook.sa

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • St Bartholomew'S Hospital
    • Contact: Jawza Aldakhil; Email: jawza.aldakhil@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Recruitment will take place from the out-patient clinics & echocardiography laboratory at St Bartholomew's Hospital

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effective Regurgitant Orifice Area at 1 year	Measure the EROA by echocardiography after 1 year	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression of valve disease defined as worsening of mitral or tricuspid regurgitation > 1 grade at 1 year.	Measure the change in regurgitation severity	1 year
Functional: New York Heart Association Class, Predicted VO2max (<84%).	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)	1 year
Heart Failure admission within 1 year of recruitment.	incidence of heart failure admissions within a one-year period following the recruitment of participants.	1 year
Mortality	Document and analyze the mortality rates among participants	1 year

Collaborators and Investigators

• Sponsor: Barts & The London NHS Trust
• Investigators: Principal Investigator: Sanjeev bhattacharyya, Barts & The London NHS Trust; Study Chair: Jawza Aldakhil, Barts & The London NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: June 16, 2023
• First Submitted That Met QC Criteria: June 16, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Cardiac Imaging Techniques; Ultrasonography; Echocardiography
• Other Study ID Numbers: 326447

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No