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NCT06738615 · ClinicalTrials.gov registry record
Assessing the Relationship Between Symptoms and Mitral Regurgitnant. Severity
A clinical trial of Mitral Insufficiency, sponsored by Atlantic Health System.
- Recruiting
- Registry status
- 40
- Enrollment target
- 1
- Study location
NCT06738615: Recruiting study of Mitral Insufficiency, sponsored by Atlantic Health System.
NCT06738615 is a study of Mitral Insufficiency that is actively recruiting participants, run by Atlantic Health System. The registered enrollment target is 40 participants, below the 562-participant average among 5 other Mitral Insufficiency trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06738615, a study of Mitral Insufficiency, is actively recruiting participants, sponsored by Atlantic Health System.
- RECRUITING
- Registry status
- 40 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Assess the relationship between diastolic dysfunction. Diastolic dysfunction is measured by pressure volume loop assessment. Diastolic disfunction will be compared to patients symptom burden (as quantified by KCCQ) and exercise capacity (as quantified by CPET).
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Pressure volume loop evaluation
- DIAGNOSTIC_TEST cardiovascular magnetic resonance imaging
- DIAGNOSTIC_TEST Cardiopulmonary exercise testing (CPET)
- DIAGNOSTIC_TEST Kansas City Cardiomyopathy Questionairre
Study Locations (1)
New Jersey
- Morristown Medical Center - Morristown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-01-02 |
| Est. Completion | 2027-05-02 |
What NCT06738615 shows while recruiting
NCT06738615 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 562-participant average among 5 other Mitral Insufficiency trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Mitral Insufficiency appearing as the primary indexed condition, and to 4 interventions - of which Pressure volume loop evaluation is the first listed.
NCT06738615 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT06738615 about?
NCT06738615 is a clinical study titled "Assessing the Relationship Between Symptoms and Mitral Regurgitnant. Severity". 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 accu...
What is the current status of trial NCT06738615?
This trial is currently recruiting. The enrollment target is 40 participants. The study started on 2025-01-02. Estimated completion is 2027-05-02.
What conditions does trial NCT06738615 study?
This clinical trial studies the following conditions: Mitral Insufficiency.
What interventions are being tested in trial NCT06738615?
The interventions under investigation include: Pressure volume loop evaluation (DIAGNOSTIC_TEST), cardiovascular magnetic resonance imaging (DIAGNOSTIC_TEST), Cardiopulmonary exercise testing (CPET) (DIAGNOSTIC_TEST), Kansas City Cardiomyopathy Questionairre (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06738615?
This trial is sponsored by Atlantic Health System, which has 43 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06738615 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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