NCT02355418

Brief Summary

This study investigates the hypothesis that diffuse interstitial cardiac fibrosis develops in response to chronic volume overload from severe degenerative mitral regurgitation. The investigators will investigate the functional (exercise) and symptomatic (PROMS) outcomes of patients with severe but asymptomatic mitral regurgitation who have the option of choosing surgical repair or watchful waiting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 4, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

March 14, 2022

Status Verified

March 1, 2022

Enrollment Period

3.5 years

First QC Date

January 30, 2015

Last Update Submit

March 10, 2022

Conditions

Mitral Valve RegurgitationMitral Regurgitation

Outcome Measures

Primary Outcomes (1)

  • Detection of diffuse interstitial fibrosis in patients with chronic severe degenerative mitral regurgitation and evaluation of its functional consequences.

    Using T1-mapping CMR and myocardial biopsy, the investigators can confirm the development of diffuse interstitial fibrosis in patients with chronic severe degenerative mitral regurgitation. Using a range of clinical markers, the investigators will study the development of diffuse interstitial fibrosis and its relationship to left ventricular recovery following surgery, length of in-hospital stay, and patients' functional (exercise) and symptomatic (PROMS) status.

    3 years

Study Arms (2)

Patients for early surgery

A prospective, cross sectional comparison of asymptomatic patients before and after mitral valve repair surgery for chronic severe primary degenerative mitral regurgitation.Once established, it is our intention to restudy subjects in 5 years to provide information on late outcome following surgery.

Procedure: Mitral valve repair

Patients against early surgery

In order to establish the natural history of diffuse fibrosis in mitral regurgitation, an additional cohort of patients with asymptomatic mitral regurgitation who do not wish to consider early repair will be followed.

Interventions

Mitral valve repairPROCEDURE

Standard mitral valve repair surgery

Patients for early surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with asymptomatic chronic, severe primary degenerative mitral regurgitation (MR) under clinical follow-up or on the surgical waiting list at Queen Elizabeth Hospital Birmingham (QEHB). Aetiology and severity of MR will be based on the findings of echocardiography.

You may qualify if:

  • (1) All patients with asymptomatic chronic, severe primary degenerative MR known to the Queen Elizabeth Hospital Birmingham (of note, the aetiology and severity of MR will be based on the echocardiography findings , interpreted according to the European Association of Echocardiography recommendations).

You may not qualify if:

  • symptoms due to severe MR;
  • LV endsystolic diameter \>45mm at baseline;
  • LV ejection fraction \<60%;
  • history of myocardial infarction, previous coronary artery bypass graft, or valve surgery;
  • inherited or acquired cardiomyopathy;
  • congenital heart disease; including common atrio-ventricular canal defects;
  • more than mild coexisting aortic valve stenosis or regurgitation
  • primary mitral regurgitation not due to degenerative disease, including rheumatic disease and infective endocarditis;
  • uncontrolled atrial fibrillation (resting HR\>100/min average on 24 hour Holter );
  • unable to undergo CMR;
  • unable to walk on treadmill or use supine bicycle.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Birmingham

Birmingham, West Midlands, B15 2TH, United Kingdom

Location

Related Publications (3)

  • Liu B, Neil DAH, Bhabra M, Patel R, Barker TA, Nikolaidis N, Billing JS, Hayer M, Baig S, Price AM, Vijapurapu R, Treibel TA, Edwards NC, Steeds RP. Reverse Myocardial Remodeling Following Valve Repair in Patients With Chronic Severe Primary Degenerative Mitral Regurgitation. JACC Cardiovasc Imaging. 2022 Feb;15(2):224-236. doi: 10.1016/j.jcmg.2021.07.007. Epub 2021 Aug 18.

    PMID: 34419393DERIVED

  • Liu B, Neil DAH, Premchand M, Bhabra M, Patel R, Barker T, Nikolaidis N, Billing JS, Treibel TA, Moon JC, Gonzalez A, Hodson J, Edwards NC, Steeds RP. Myocardial fibrosis in asymptomatic and symptomatic chronic severe primary mitral regurgitation and relationship to tissue characterisation and left ventricular function on cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2020 Dec 14;22(1):86. doi: 10.1186/s12968-020-00674-4.

    PMID: 33308240DERIVED

  • Liu B, Edwards NC, Neal DAH, Weston C, Nash G, Nikolaidis N, Barker T, Patel R, Bhabra M, Steeds RP. A prospective study examining the role of myocardial Fibrosis in outcome following mitral valve repair IN DEgenerative mitral Regurgitation: rationale and design of the mitral FINDER study. BMC Cardiovasc Disord. 2017 Nov 22;17(1):282. doi: 10.1186/s12872-017-0715-y.

    PMID: 29166877DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be taken from all patients as part of their routine care, including measurements for full blood count, urea and electrolytes, liver function test, and markers of cardiac fibrosis. In patients who chooses to undergo surgical repair of mitral regurgitation, myocardial biopsies will be taken to look for the degree of diffuse myocardial fibrosis.

MeSH Terms

Conditions

Mitral Valve Insufficiency

Interventions

Mitral Valve Annuloplasty

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Valve AnnuloplastyCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Richard Steeds

    University Hospital Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiology Research Fellow

Study Record Dates

First Submitted

January 30, 2015

First Posted

February 4, 2015

Study Start

September 1, 2015

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

March 14, 2022

Record last verified: 2022-03

Locations

GB(1)