Atrial Functional Mitral Regurgitation and Tricuspid Regurgitation
Clinical Phenotypes, Risk Factors, & Determinants of Outcome in Functional Mitral and Tricuspid Valve Regurgitation
1 other identifier
observational
141
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2023
CompletedFirst Posted
Study publicly available on registry
June 27, 2023
CompletedStudy Start
First participant enrolled
August 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
April 21, 2026
April 1, 2026
3.9 years
June 16, 2023
April 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Effective Regurgitant Orifice Area at 1 year
Measure the EROA by echocardiography after 1 year
1 year
Secondary Outcomes (4)
Progression of valve disease defined as worsening of mitral or tricuspid regurgitation > 1 grade at 1 year.
1 year
Functional: New York Heart Association Class, Predicted VO2max (<84%).
1 year
Heart Failure admission within 1 year of recruitment.
1 year
Mortality
1 year
Interventions
Ultrasound scan of the heart
Eligibility Criteria
Recruitment will take place from the out-patient clinics \& echocardiography laboratory at St Bartholomew's Hospital
You may qualify if:
- 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.
You may not qualify if:
- Unwilling or unable to give consent
- Left ventricular impairment (ejection fraction \< 50%).
- Primary/organic valve disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St Bartholomew's Hospital
London, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sanjeev bhattacharyya
Barts & The London NHS Trust
- STUDY CHAIR
Jawza Aldakhil
Barts & The London NHS Trust
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2023
First Posted
June 27, 2023
Study Start
August 23, 2023
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
April 21, 2026
Record last verified: 2026-04