Understanding valve disease in patients with atrial fibrillation
Clinical Phenotypes, Risk Factors, & Determinants of Outcome in Functional Mitral and Tricuspid Valve Regurgitation
This study is trying to understand different types of valve problems in people with atrial fibrillation to see how they affect health and what might make them worse over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 141 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Barts & The London NHS Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT05920824 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to identify clinical phenotypes and evaluate predictors and outcomes of functional mitral and tricuspid valve regurgitation in patients diagnosed with atrial fibrillation. Participants will undergo baseline echocardiography, blood tests, and follow-up echocardiography over one year. The study will stratify participants into three subgroups based on their valve disease: atrial functional mitral regurgitation, atrial functional tricuspid regurgitation, and mixed disease. The primary objective is to characterize these phenotypes and identify risk factors for disease progression.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with atrial fibrillation and moderate to severe atrial valve disease.
Not a fit: Patients with left ventricular impairment or primary/organic valve disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of valve disease in patients with atrial fibrillation.
How similar studies have performed: While the natural history of atrial valve disease is not well understood, similar observational studies have provided valuable insights into other cardiovascular conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
London
- St Bartholomew's Hospital — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Sanjeev bhattacharyya — Barts & The London NHS Trust
- Study coordinator: Jawza Aldakhil
- Email: Jawza@outlook.sa
- Phone: 00447899770693
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.