Last reviewed · How we verify
NCT07066904: FLAME
Quantification of Mitral Regurgitation Using 4D MRI Flow : Comparison With 2D MRI Flow and Echocardiography Using the Evolution of Left Ventricular Remodeling as a Reference
NA trial testing Standard echocardiography in Mitral Regurgitation (MR) in 160 participants. Not yet recruiting.
30 April 2028
Quick facts
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 160 |
| Start date | 1 October 2025 |
| Primary completion | 30 April 2028 |
| Estimated completion | 30 April 2028 |
| Sites | 3 locations across France |
Drugs / interventions tested
- Standard echocardiography
- 2D phase-contrast magnetic resonance imaging
- 4D flow magnetic resonance imaging
- Cardiac ultrafast ultrasound imaging
Conditions studied
- Mitral Regurgitation (MR) — all drugs for Mitral Regurgitation (MR) →
Sponsor
Assistance Publique - Hôpitaux de Paris — full company profile →
Who can join
Adults 18 to 85, any sex, with Mitral Regurgitation (MR). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this study is to evaluate whether 4D MRI provides a better assessment of mitral regurgitation quantification and associated ventricular remodeling than standard imaging techniques: echocardiography and 2D MRI, in patients suffuring from mitral regurgitation. 4D MRI demonstrated its superiority to 2D MRI in some other valve diseases but remains not widely used, due to a lack of evidence. The main question our study aims to answer is: • Is mitral regurgitant volume measured on 4D MRI more strongly related to remodeling progression (after correction of regurgitation or not) than regurgitant volume measured on 2D MRI and echocardiography? Participants will undergo 4D MRI, 2D MRI and echocardiography twice at six-month intervals.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07066904
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Standard echocardiography
Trials testing the same drug.
- NCT03850015 — High Frame Rate Ultrasound in Heart Disease Assessment · recruiting
Other recruiting trials for Mitral Regurgitation (MR)
Currently open trials in the same condition.
- NCT07197736 — DELINEATE-Prospective · recruiting
- NCT07501234 — Safety and Feasibility Study of the MitraFix® Transcatheter Mitral Valve System · NA · recruiting
- NCT06816888 — Impact of Automatic Prompts in Echocardiographic Reports on Referral to Cardiology · NA · active not recruiting
- NCT06876883 — MItral Regurgitation Risk Assessment and CLinical modElling · recruiting
- NCT07045753 — The Prospective Segeberg Registry for Mitral Transcatheter Edge-to-Edge Repair · recruiting
Other Assistance Publique - Hôpitaux de Paris trials
Trials by the same sponsor.
- NCT07443436 — Immunomodulatory Treatment of Interstitial Lung Disease Associated With Surfactant Related Gene Variants · Phase 2 · not yet recruiting
- NCT07499492 — Red Blood Cell Transfusion to Optimize Extubation · NA · not yet recruiting
- NCT07379918 — Real-life Evaluation of Endopredict® in Early HR+/HER2- Breast Cancer · recruiting
- NCT07473869 — Smartphone Application for Automated Measurement of Capillary Refill Time (CRT) · not yet recruiting
- NCT07505394 — Efficacy of a Prediction Model-based Algorithm to PREVENT Drug-induced Impulse Control Disorders in Parkinson's Disease · NA · not yet recruiting
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 NCT07066904 (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 Assistance Publique - Hôpitaux de Paris
- Last refreshed: 15 July 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/NCT07066904.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing