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NCT05965258
Phenotypic Classification of FMR With CMR
trial testing Cardiac magnetic resonance (CMR) in Nonischemic Congestive Cardiomyopathy in 360 participants. Currently enrolling.
31 December 2028
Quick facts
| Lead sponsor | The Cleveland Clinic |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 360 |
| Start date | 29 August 2023 |
| Primary completion | 31 December 2028 |
| Estimated completion | 31 December 2028 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Cardiac magnetic resonance (CMR)
Conditions studied
- Nonischemic Congestive Cardiomyopathy — all drugs for Nonischemic Congestive Cardiomyopathy →
- Functional Mitral Regurgitation — all drugs for Functional Mitral Regurgitation →
- Ischemic Cardiomyopathy — all drugs for Ischemic Cardiomyopathy →
Sponsor
The Cleveland Clinic
Who can join
18 and older, any sex, with Nonischemic Congestive Cardiomyopathy or Functional Mitral Regurgitation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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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 NCT05965258 (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 The Cleveland Clinic
- Last refreshed: 20 October 2025
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/NCT05965258.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing