Recruiting

Observational Study

Sponsor:

Atlantic Health System

Code:

NCT04051411

Conditions

Mitral Regurgitation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Mitral Regurgitation

Study ID

NCT04051411

Start date

Aug 7, 2019

Status verified date

Aug, 2019

Completion date

Jan, 2024

Anticipated

Primary completion date

Jan, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Change in mitral regurgitant volume [ Time Frame: Entry into study, 1 year, and 2 years ]

Central Contacts and Locations

Central contacts

Locations

Morristown Medical Center

Recruiting

Morristown, New Jersey, United States, 07960

Contacts

Principal Investigator:

Seth Uretsky, MD

More Information

Sponsor

Atlantic Health System

Last update posted

Aug 21, 2019

Last verified

Aug, 2019

Keywords

  • mitral regurgitation
  • echocardiography
  • MRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Atlantic Health System on 2019-08-21.