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NCT06738615
Assessing the Relationship Between Symptoms and Mitral Regurgitnant. Severity
trial testing Pressure volume loop evaluation in Mitral Insufficiency in 40 participants. Currently enrolling.
2 January 2027
Quick facts
| Lead sponsor | Atlantic Health System |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 40 |
| Start date | 2 January 2025 |
| Primary completion | 2 January 2027 |
| Estimated completion | 2 May 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Pressure volume loop evaluation
- cardiovascular magnetic resonance imaging
- Cardiopulmonary exercise testing (CPET)
- Kansas City Cardiomyopathy Questionairre
Conditions studied
- Mitral Insufficiency — all drugs for Mitral Insufficiency →
Sponsor
Atlantic Health System — full company profile →
Who can join
18 and older, male only, with Mitral Insufficiency. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06738615
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Atlantic Health System trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06738615 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Atlantic Health System
- Last refreshed: 17 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06738615.
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