Atrial Functional Mitral Regurgitation and Tricuspid Regurgitation
NCT ID: NCT05920824
Last Updated: 2025-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
141 participants
OBSERVATIONAL
2023-12-01
2027-02-28
Brief Summary
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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
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Echocardiogram
Ultrasound scan of the heart
Eligibility Criteria
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Inclusion Criteria
* 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
* Left ventricular impairment (ejection fraction \< 50%).
* Primary/organic valve disease
18 Years
ALL
No
Sponsors
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Barts & The London NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Sanjeev bhattacharyya
Role: PRINCIPAL_INVESTIGATOR
Barts & The London NHS Trust
Jawza Aldakhil
Role: STUDY_CHAIR
Barts & The London NHS Trust
Locations
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St Bartholomew's Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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326447
Identifier Type: -
Identifier Source: org_study_id
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