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NCT05965258 · ClinicalTrials.gov registry record
Phenotypic Classification of FMR With CMR
A clinical trial of Ischemic Cardiomyopathy and Functional Mitral Regurgitation, sponsored by The Cleveland Clinic.
- Recruiting
- Registry status
- 360
- Enrollment target
- 1
- Study location
NCT05965258: Recruiting study of Ischemic Cardiomyopathy and Functional Mitral Regurgitation, sponsored by The Cleveland Clinic.
NCT05965258 is a study of Ischemic Cardiomyopathy and Functional Mitral Regurgitation that is actively recruiting participants, run by The Cleveland Clinic. The registered enrollment target is 360 participants, roughly in line with the 343-participant average among 10 other Ischemic Cardiomyopathy trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05965258, a study of Ischemic Cardiomyopathy and Functional Mitral Regurgitation, is actively recruiting participants, sponsored by The Cleveland Clinic.
- RECRUITING
- Registry status
- 360 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of the current research is to develop personalized risk prediction for functional mitral regurgitation (FMR) patients through explainable unsupervised phenomapping enriched with advanced cardiac magnetic resonance (CMR) imaging biomarkers, and to determine the CMR predictors of reverse remodeling following modern therapies for FMR. The prospective study entails aiming to recruit 360 adult patients (ages \>18 years) with EF 10-50% and FMR RF\> 20%, who are clinically referred for CMR evaluation. Patients who enroll in our study will be referred for optimization of mGDMT and will undergo follow-up CMR studies at 6months. NICM patients who are fully medically optimized with significant FMR at the time of the baseline CMR and are referred for Mitraclip treatment will undergo follow-up CMR 6 months from Mitraclip intervention. NICM patients referred for mGDMT optimization, but have persistent or progressive FMR at the time of 6 month follow-up CMR and referred for Mitraclip therapy, will undergo a 2nd follow-up CMR 6 months from Mitraclip therapy.
Primary Outcome
Occurrence of cardiac mortality and/or heart transplant and/or LVAD implantation
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Cardiac magnetic resonance (CMR)
Study Locations (1)
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2023-08-29 |
| Est. Completion | 2028-12-31 |
What NCT05965258 shows while recruiting
NCT05965258 is an observational study that tracks outcomes without assigning an intervention. The registered 360 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 343-participant average among 10 other Ischemic Cardiomyopathy trials with a reported enrollment target.
The record links to 3 conditions, with Ischemic Cardiomyopathy appearing as the primary indexed condition, and to 1 intervention - of which Cardiac magnetic resonance (CMR) is the first listed.
NCT05965258 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT05965258 about?
NCT05965258 is a clinical study titled "Phenotypic Classification of FMR With CMR". The goal of the current research is to develop personalized risk prediction for functional mitral regurgitation (FMR) patients through explainable unsupervised phenomapping enriched with advanced cardiac magnetic resonance (CMR) imaging biomarkers, and to determine the CMR predictors of reverse remo...
What is the current status of trial NCT05965258?
This trial is currently recruiting. The enrollment target is 360 participants. The study started on 2023-08-29. Estimated completion is 2028-12-31.
What conditions does trial NCT05965258 study?
This clinical trial studies the following conditions: Ischemic Cardiomyopathy, Functional Mitral Regurgitation, Nonischemic Congestive Cardiomyopathy.
What interventions are being tested in trial NCT05965258?
The interventions under investigation include: Cardiac magnetic resonance (CMR) (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05965258?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05965258 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05965258's enrollment target sits among peer trials
360 3rd of 10 higher than 8 of 10 other Ischemic Cardiomyopathy trials
participants (enrollment target), bucketed by value
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