Clinical Phenotypes, Risk Factors, & Determinants of Outcome in Functional Mitral and Tricuspid Valve Regurgitation
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Barts & The London NHS Trust
- Enrollment
- 141
- Locations
- 1
- Primary Endpoint
- Effective Regurgitant Orifice Area at 1 year
- Status
- Recruiting
- Last Updated
- 11 days ago
Overview
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
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
Investigators
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
Outcomes
Primary Outcomes
Effective Regurgitant Orifice Area at 1 year
Time Frame: 1 year
Measure the EROA by echocardiography after 1 year
Secondary Outcomes
- Heart Failure admission within 1 year of recruitment.(1 year)
- Mortality(1 year)
- Functional: New York Heart Association Class, Predicted VO2max (<84%).(1 year)
- Progression of valve disease defined as worsening of mitral or tricuspid regurgitation > 1 grade at 1 year.(1 year)