St Bartholomew's Hospital
London, United Kingdom
Location status: Recruiting
NCT Number: NCT05920824
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
Interested in participating?
Request Info18 year and older
All sexes
Observational
London, United Kingdom
Location status: Recruiting
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
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
Recruitment will take place from the out-patient clinics & echocardiography laboratory at St Bartholomew's Hospital
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ultrasound scan of the heart
Time frame: 1 year
Measure the EROA by echocardiography after 1 year
Time frame: 1 year
Measure the change in regurgitation severity
Time frame: 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)
Time frame: 1 year
incidence of heart failure admissions within a one-year period following the recruitment of participants.
Time frame: 1 year
Document and analyze the mortality rates among participants
Contact information is provided by the study sponsor or research team.
Barts & The London NHS Trust
Other
Clinical Phenotypes, Risk Factors, & Determinants of Outcome in Functional Mitral and Tricuspid Valve Regurgitation
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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