Health TrialsbyHealthPanel

Atrial Functional Mitral Regurgitation and Tricuspid Regurgitation

ConditionsAtrial FibrillationFunctional Mitral RegurgitationFunctional Tricuspid Regurgitation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBarts & The London NHS Trust

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Informed consent

Age of 18 years or older

Atrial fibrillation

Moderate or severe atrial valve disease

Disqualifiers

Unwilling or unable to give consent

Left ventricular impairment (ejection fraction < 50%).

Primary/organic valve disease

Trial population

Recruitment will take place from the out-patient clinics \& echocardiography laboratory at St Bartholomew's Hospital

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Echocardiogram

    Diagnostic test

    Ultrasound scan of the heart

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Effective Regurgitant Orifice Area at 1 year

Measure the EROA by echocardiography after 1 year

Time frame
1 year

Secondary outcomes

1

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

Measure the change in regurgitation severity

Time frame
1 year
2

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)

Time frame
1 year
3

Heart Failure admission within 1 year of recruitment.

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

Time frame
1 year
4

Mortality

Document and analyze the mortality rates among participants

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Barts & The London NHS Trust

Lead sponsor

Source ClinicalTrials.gov
Apply now