Atrial Functional Mitral Regurgitation and Tricuspid Regurgitation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Echocardiogram.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation, Functional Mitral Regurgitation, Functional Tricuspid Regurgitation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Phenotypes, Risk Factors, & Determinants of Outcome in Functional Mitral and Tricuspid Valve Regurgitation
Overview
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
Interventions
- Diagnostic test Echocardiogram
Ultrasound scan of the heart
Primary outcome measures
- Effective Regurgitant Orifice Area at 1 year [Time frame: 1 year]
Secondary outcome measures (4)
- Progression of valve disease defined as worsening of mitral or tricuspid regurgitation > 1 grade at 1 year. [Time frame: 1 year]
- Functional: New York Heart Association Class, Predicted VO2max (<84%). [Time frame: 1 year]
- Heart Failure admission within 1 year of recruitment. [Time frame: 1 year]
- Mortality [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- St Bartholomew's Hospital — London
Identifiers
NCT: NCT05920824 · 326447