NCT06738615 Assessing the Relationship Between Symptoms and Mitral Regurgitnant. Severity
| NCT ID | NCT06738615 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Atlantic Health System |
| Condition | Mitral Insufficiency |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-01-02 |
| Primary Completion | 2027-01-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2025-01-02 with a primary completion date of 2027-01-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The current American College of Cardiology/American Heart Association (ACC/AHA) guidelines recommend surgery in patient with mitral regurgitation (MR) based on 1) the severity of MR and 2) the presence or absence of symptoms. Studies have shown that Cardiovascular Magnetic Resonance (CMR) is an accurate method to quantify the severity of MR. However, studies have also shown that symptoms are not necessarily related to the presence of symptoms. Thus, there appears to be a disconnect between the severity of MR and symptoms. Recent analysis of our data has shown that females and older patients with smaller ventricles, lower stroke volumes, and lower regurgitant volume relative to regurgitant fraction tend to be symptomatic. These findings suggest that decreased left ventricular compliance, i.e. diastolic dysfunction, may play an important role as an etiology of symptoms in patients with mitral regurgitation. The aim of this study is to study the presence of diastolic dysfunction in patients with MR and its association with symptom burden and exercise capacity.
Eligibility Criteria
Inclusion Criteria: * Age \>=18 years of age * Able to give informed consent * Primary (degenerative) mitral regurgitation * LVEF \>=50% * Undergoing cardiac catheterization * Able to exercise on a treadmill Exclusion Criteria: * Unable to give informed consent * Secondary (functional) mitral regurgitation * LVEF \<50% * Known coronary artery stenosis \>=70% or past revascularization * More than mild aortic stenosis, mitral stenosis, aortic regurgitation, tricuspid regurgitation, or pulmonic regurgitation * Hypertrophic cardiomyopathy * Pregnancy
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06738615 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Mitral Insufficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06738615 currently recruiting?
Yes, NCT06738615 is actively recruiting participants. Contact the research team at seth.uretsky@atlantichealth.org for enrollment information.
Where is the NCT06738615 trial being conducted?
This trial is being conducted at Morristown, United States.
Who is sponsoring the NCT06738615 clinical trial?
NCT06738615 is sponsored by Atlantic Health System. The trial plans to enroll 40 participants.