Clinical trial NCT05920824: Atrial Functional Mitral Regurgitation and Tricuspid Regurgitation
Official title: Clinical Phenotypes, Risk Factors, & Determinants of Outcome in Functional Mitral and Tricuspid Valve Regurgitation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Functional Mitral Regurgitation
Functional Tricuspid Regurgitation
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recruitment will take place from the out-patient clinics \& echocardiography laboratory at St Bartholomew's Hospital

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

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

Primary outcomes:
measure: Effective Regurgitant Orifice Area at 1 year
timeFrame: 1 year
Secondary outcomes:
measure: Progression of valve disease defined as worsening of mitral or tricuspid regurgitation > 1 grade at 1 year.
timeFrame: 1 year
measure: Functional: New York Heart Association Class, Predicted VO2max (<84%).
timeFrame: 1 year
measure: Heart Failure admission within 1 year of recruitment.
timeFrame: 1 year
measure: Mortality
timeFrame: 1 year
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
Study officials:
affiliation: Barts & The London NHS Trust
name: Sanjeev bhattacharyya
role: PRINCIPAL_INVESTIGATOR
affiliation: Barts & The London NHS Trust
name: Jawza Aldakhil
role: STUDY_CHAIR
References: