Recruiting

Mitral RegurgitationDeterminants of the Progression and Outcome of Mitral Regurgitation

Sponsor:

Laval University

Code:

NCT01835054

Conditions

Mitral Valve Insufficiency

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Blood biomarkers

DNA collection

Echocardiography

Cardiopulmonary exercise testing

Magnetic resonance imaging (MRI)

Study Details

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.

Conditions

Mitral Valve Insufficiency

Study ID

NCT01835054

Start date

Dec, 2008

Status verified date

Oct, 2021

Completion date

Mar, 2024

Anticipated

Primary completion date

Mar, 2024

Anticipated

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Age > 18 or 21 years (Legal age according to the countries involved in this study)
Presence of at least mild chronic OMR defined as an ERO ≥10mm2 and/or a regurgitant volume ≥20mL

Exclusion Criteria:

MR due to ischemic heart disease or cardiomyopathy
> mild mitral stenosis, aortic regurgitation, aortic stenosis or pulmonary stenosis
previous valve operation
history of myocardial infarction or angiographycally documented coronary stenosis
congenital or pericardial heart disease
endocarditis
contra-indication or inability to exercise
pregnancy
Class I or IIa indication for mitral valve operation according to the 2014 ACC/AHA/ESC guidelines
Typical contraindications to contrast-enhanced MRI (surgery in the last 3 months, defibrillator, pericardial electrodes, brain surgery, aneurysm clipping, neurostimulator, electric stimulation device or magnetically activated, cochlear implant, insulin pump or medication delivery device, Swan-Ganz catheter)

Study Design

Enrollment

440 participants

Anticipated

Interventions and Outcome Measures

Arms

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.).

Interventions

Blood biomarkers