Atrial Functional Mitral Regurgitation and Tricuspid Regu... | NCT05920824

Studies
Atrial Functional Mitral Regurgitation and Tricuspid Regurgitation

NCT05920824

Sponsor

Barts & The London NHS Trust

Status

Recruiting

Last Update Posted

Apr 21, 2026Actual

Enrollment

141Estimated

Phase

Not provided

Conditions

Atrial Fibrillation
Functional Mitral Regurgitation
Functional Tricuspid Regurgitation

Interventions

Echocardiogram

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 23, 2023Actual

Primary Completion Date

Aug 2027Estimated

Completion Date

Aug 2027Estimated

First Submitted Date

Jun 16, 2023

First Submission Date that Met QC Criteria

Jun 16, 2023

First Posted Date

Jun 27, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2026

Last Update Posted Date

Apr 21, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

141Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Echocardiogram	Diagnostic Test	Ultrasound scan of the heart

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effective Regurgitant Orifice Area at 1 year	Measure the EROA by echocardiography after 1 year	1 year

Secondary Outcomes

Measure	Description	Time Frame
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
Functional: New York Heart Association Class, Predicted VO2max (<84%).

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jawza Aldakhil	Contact	00447899770693		Jawza@outlook.sa

Overall Officials

Name	Affiliation	Role
Sanjeev bhattacharyya	Barts & The London NHS Trust	Principal Investigator
Jawza Aldakhil	Barts & The London NHS Trust	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Bartholomew's Hospital	Recruiting	London			United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004452	Echocardiography

Ancestor Terms

ID	Term
D057791	Cardiac Imaging Techniques
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided