Brief Summary

Mitral regurgitation (MR) is one of the most frequent valve lesions, both in North America and in Europe, and its prevalence is increasing with the aging of the population. Organic Mitral Regurgitation (OMR) and Ischemic Mitral Regurgitation are the 2 main categories of MR. Organic or primary MR is caused by an anatomic alteration of the valvular or subvalvular mitral apparatus and refers to rheumatic MR and degenerative MR that includes mitral leaflet prolapse and flail leaflet. In the past 20 years, degenerative MR has become, by far, the most frequent cause of severe MR leading to surgery in the western world. However, the best current treatment for OMR remains uncertain and controversial. We have obtained preliminary data showing that OMR is a dynamic lesion. Hence, the echocardiographic evaluation of MR at rest, as generally performed during routine clinical exam, does not necessarily reflect the status of MR during patient's daily activities and thereby does not adequately assess the risk of rapid progression and poor outcome in these patients. The objective of this study is to identify the independent predictors of disease progression and outcome in patients with asymptomatic chronic OMR and to develop and validate novel imaging and circulating biomarkers to improve risk stratification and therapeutic decision-making process in patients with chronic asymptomatic primary OMR.

Trial Health

At Risk

Trial Health Score

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

Trial has exceeded expected completion date

Enrollment

440

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Dec 2008

Longer than P75 for all trials

Geographic Reach

3 countries

4 active sites

Status

unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

15.3 years study duration

Study Start

First participant enrolled

December 1, 2008

Completed

4.4 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2013

Completed

2 days until next milestone

First Posted

Study publicly available on registry

April 18, 2013

Completed

10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed

Last Updated

October 28, 2021

Status Verified

October 1, 2021

Enrollment Period

15.3 years

First QC Date

April 16, 2013

Last Update Submit

October 27, 2021

Conditions

Mitral Valve Insufficiency

Keywords

Mitral regurgitationMitral valve prolapseEchocardiography, DopplerStress echocardiographyCardiopulmonary exercice testingMagnetic Resonance ImagingCardiac neurohormonesVisceral obesityCardiometabolic riskRisk stratification

Outcome Measures

Primary Outcomes (1)

Combined clinical and echocardiographic endpoint
The primary outcome is the time to occurrence of the first composite end-point: development of symptoms, left ventricular (LV) dysfunction (LV Ejection Fraction\<60% and/or LV end diastolic diameter \>40mm), ventricular arrhytmia requiring hospitalization, mediaction and/or implantation of defibrillator, atrial fibrillation or flutter, pulmonary arterial hypertension (resting systolic pressure \>50mmHg), occurence of pulmonary oedema, congestive heart failure or cardiovascular death.
Patients will be followed for 10 years

Secondary Outcomes (8)

Progression of MR severity
Patients will be followed for 10 years
Progression of pulmonary arterial hypertension
Patients will be folowed for 10 years
Progression of LV dysfuntion prior to surgery
Patients will be followed for 10 years
Maximum exercise capacity at baselin and following mitral valve surgery
Patients will be followed for 10 years
Composite end-point prior to mitral valve surgery
Patients will be followed for 10 years
+3 more secondary outcomes

Study Arms (1)

Patients with mitral regurgitation

At study entry, patients have 1) a clinical assessment including metabolic risk profile; 2) a blood sample for analysis of metabolic, cardiac neurohormonal blood biomarkers and DNA collection; 3) a complete rest doppler echocardiography; 4) an exercise stress doppler echocardiography; 5) a cardiopulmonary exercise testing; 6) a magnetic resonance Imaging (MRI); 7) a 24-hour Holter ECG. At follow-up, patients have 1) a clinical events assessment; 2) a blood sample analysis; 3) a resting echocardiography every year; 4) MRI (at preop. evaluation in the subset of patients undergoing surgery); 5) a 24-hour Holter ECG (at 2-year and postop.).

Other: Blood biomarkersGenetic: DNA collectionOther: EchocardiographyOther: Cardiopulmonary exercise testingOther: Magnetic resonance imaging (MRI)Other: Exercise stress doppler echocardiographyOther: Holter ECG