Atrial Fibrillation, Functional Mitral Regurgitation, Functional Tricuspid Regurgitation
Conditions
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
Interventions
DIAGNOSTIC_TESTEchocardiogram
Ultrasound scan of the heart
Sponsors
Barts & The London NHS Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effective Regurgitant Orifice Area at 1 year | 1 year | Measure the EROA by echocardiography after 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression of valve disease defined as worsening of mitral or tricuspid regurgitation > 1 grade at 1 year. | 1 year | Measure the change in regurgitation severity |
| Functional: New York Heart Association Class, Predicted VO2max (<84%). | 1 year | 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) |
| Heart Failure admission within 1 year of recruitment. | 1 year | incidence of heart failure admissions within a one-year period following the recruitment of participants. |
| Mortality | 1 year | Document and analyze the mortality rates among participants |
Countries
United Kingdom
Contacts
CONTACTJawza Aldakhil
PRINCIPAL_INVESTIGATORSanjeev bhattacharyya
Barts & The London NHS Trust
STUDY_CHAIRJawza Aldakhil
Barts & The London NHS Trust
Outcome results
None listed