Determinants of the Progression and Outcome of Mitral Regurgitation

NCT01835054 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 440

Last updated 2021-10-28

No results posted yet for this study

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

Interventions

OTHER

Blood biomarkers

Observational Study using Imaging and Biomarkers

GENETIC

DNA collection

Observational Study using Imaging and Biomarkers

OTHER

Echocardiography

Observational Study using Imaging and Biomarkers

OTHER

Cardiopulmonary exercise testing

Observational Study using Imaging and Biomarkers

OTHER

Magnetic resonance imaging (MRI)

Observational Study using Imaging and Biomarkers

OTHER

Exercise stress doppler echocardiography

Observational Study using Imaging and Biomarkers

OTHER

Holter ECG

Observational Study using Imaging and Biomarkers

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV
  • Heart and Stroke Foundation of Canada

    collaborator OTHER
  • University Hospital, Brest

    collaborator OTHER
  • Laval University

    lead OTHER

Principal Investigators

  • Philippe Pibarot, PhD, DVM · Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2024-03-31
Completion
2024-03-31

Countries

  • Belgium
  • Canada
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01835054 on ClinicalTrials.gov