The Effects of Degenerative Mitral Regurgitation on Cardiac Structure and Function, Symptoms, and Exercise Capacity
Status unconfirmed
Conditions studied: Mitral Regurgitation
In brief
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.
Key facts
- Study ID
- NCT04051411
- Run by
- Atlantic Health System
- People needed
- 30
- Starts
- 2019-08-07
- Expected to finish
- 2024-01-01
- Last updated by the study team
- 2019-08-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Morristown Medical Center — Morristown, New Jersey, United States (enrolling)
Full record on ClinicalTrials.gov
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