Atrial Functional Mitral Regurgitation and Tricuspid Regurgitation

Atrial Fibrillation Clinical Trial

Official title:

Clinical Phenotypes, Risk Factors, & Determinants of Outcome in Functional Mitral and Tricuspid Valve Regurgitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05920824
• Other study ID #: 326447
• Status: Recruiting
• Start date: December 1, 2023
• Est. completion date: February 2027

Study information

• Verified date: February 2024
• Source: Barts & The London NHS Trust
• Contact: Jawza Aldakhil
• Phone: 00447899770693
• Email: Jawza[@]outlook.sa
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 141
• Est. completion date: February 2027
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Functional Mitral Regurgitation
• Functional Tricuspid Regurgitation
• Mitral Valve Insufficiency
• Tricuspid Valve Insufficiency

Intervention

Diagnostic Test:
• Echocardiogram
Ultrasound scan of the heart

Locations

Country	Name	City	State
United Kingdom	St Bartholomew's Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Barts & The London NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective Regurgitant Orifice Area at 1 year	Measure the EROA by echocardiography after 1 year	1 year
Secondary	Progression of valve disease defined as worsening of mitral or tricuspid regurgitation > 1 grade at 1 year.	Measure the change in regurgitation severity	1 year
Secondary	Functional: New York Heart Association Class, Predicted VO2max (<84%).	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)	1 year
Secondary	Heart Failure admission within 1 year of recruitment.	incidence of heart failure admissions within a one-year period following the recruitment of participants.	1 year
Secondary	Mortality	Document and analyze the mortality rates among participants	1 year