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NCT Number: NCT05920824

Atrial Functional Mitral Regurgitation and Tricuspid Regurgitation

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

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Bartholomew's Hospital

London, United Kingdom

Location status: Recruiting

Location contact

Jawza Aldakhil

CONTACT

[email protected]

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echocardiogram

Diagnostic Test

Ultrasound scan of the heart

Primary outcomes

  1. Effective Regurgitant Orifice Area at 1 year

    Time frame: 1 year

    Measure the EROA by echocardiography after 1 year

Secondary outcomes

  1. Progression of valve disease defined as worsening of mitral or tricuspid regurgitation > 1 grade at 1 year.

    Time frame: 1 year

    Measure the change in regurgitation severity

  2. Functional: New York Heart Association Class, Predicted VO2max (<84%).

    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)

  3. Heart Failure admission within 1 year of recruitment.

    Time frame: 1 year

    incidence of heart failure admissions within a one-year period following the recruitment of participants.

  4. Mortality

    Time frame: 1 year

    Document and analyze the mortality rates among participants

Study contacts

Contact information is provided by the study sponsor or research team.

Jawza Aldakhil

CONTACT

[email protected]

00447899770693

Sponsors and collaborators

Lead sponsor

Barts & The London NHS Trust

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 27, 2023
Registry last updated
Jul 16, 2026

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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