NCT04051411

Brief Summary

Current American College of Cardiology/American Heart Association guidelines recommend that patients with severe degenerative mitral regurgitation be considered for mitral valve surgery. There remains a debate within the cardiology community regarding the appropriate management of patients who remain asymptomatic. In this study the investigators will perform longitudinal follow-up data with cardiac MRI to inform the prophylactic surgery vs. close follow-up debate and to better define the natural history of this condition. The investigators hypothesize, that in the majority of patients mitral regurgitation will not worsen overtime, left ventricular hemodynamics will remain stable, exercise capacity will not decline, and symptoms will not worsen during follow-up. This finding would have a significant impact on the current recommendations for treatment in patients with mitral regurgitation by supporting a conservative management approach.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

August 7, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

August 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2019

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

August 21, 2019

Status Verified

August 1, 2019

Enrollment Period

4.4 years

First QC Date

August 7, 2019

Last Update Submit

August 19, 2019

Conditions

Mitral Regurgitation

Keywords

mitral regurgitationechocardiographyMRI

Outcome Measures

Primary Outcomes (1)

  • Change in mitral regurgitant volume

    Change in mitral regurgitant volume quantified by MRI over follow-up period

    Entry into study, 1 year, and 2 years

Secondary Outcomes (5)

  • Change in left ventricular end-diastolic volume

    Entry into study, 1 year, and 2 years

  • Change in symptoms and quality

    Entry into study, 1 year, and 2 years

  • Change in exercise capacity

    Entry into study, 1 year, and 2 years

  • Follow up events

    1 yea, and 2 years

  • Change in degree of myocardial fibrosis

    Entry into study, 1 year, and 2 years

Eligibility Criteria

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

Patients diagnosed with moderate or severe mitral regurgitation by echocardiography and remain asymptomatic

You may qualify if:

  • Age \>=18 yrs
  • able to give informed consent
  • Diagnoses of moderate or severe degenerative mitral regurgitation (based on the integrated approach recommended by the American Society of Echocardiography)

You may not qualify if:

  • Left ventricular ejection fraction \<60%
  • Heart failure
  • Pulmonary hypertension (pulmonary artery systolic pressure \>40mmHg at rest or \>60mmHg with exercise as assessed by echocardiography)
  • Atrial fibrillation
  • Concomitant \> mild aortic or mitral stenosis, \>mild aortic or tricuspid or pulmonic regurgitation
  • Prior valvular heart disease surgery
  • Hypertrophic cardiomyopathy or an infiltrative cardiomyopathy
  • Unable to exercise on a treadmill
  • Symptomatic coronary artery disease
  • Comorbidities expected to impact functional capacity and confound symptom assessment (e.g COPD)
  • Expected lifespan of less than 2 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Morristown Medical Center

Morristown, New Jersey, 07960, United States

RECRUITING

Related Publications (1)

  • Uretsky S, Gillam LD, Biederman RWW, Han Y, Jacob R, Martin ET, Langer M, Choi AD, Sultan I, Cavalcante JL, Shah DJ, Tong MS, Wolff SD, Sakul S, Guglielmo M, Pontone G. Sex differences in pre- and post-surgical left ventricular remodelling and outcomes in primary mitral regurgitation. Eur Heart J Cardiovasc Imaging. 2025 Jul 31;26(8):1429-1437. doi: 10.1093/ehjci/jeaf151.

    PMID: 40392571DERIVED

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Central Study Contacts

SETH URETSKY, MD

CONTACT

9739715597seth.uretsky@atlantichealth.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director, Cardiovascular Imaging

Study Record Dates

First Submitted

August 7, 2019

First Posted

August 9, 2019

Study Start

August 7, 2019

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

August 21, 2019

Record last verified: 2019-08

Locations

US(1)