Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05965258
Status:
RECRUITING
Last Update Posted:
2023-10-27
First Post:
2023-07-20
Brief Title:
Phenotypic Classification of FMR With CMR
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Improving Phenotypic Classification and Prediction of Treatment Outcomes in Patients With Non-ischemic Cardiomyopathy and Functional Mitral Regurgitation
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Functional mitral regurgitation FMR portends a bleak prognosis and is a common consequence of ischemic and non-ischemic cardiomyopathy ICM NICM where adverse annular and left ventricular LV remodeling andor infarction alters mitral valve MV function
Prior studies demonstrate significant increases in mortality risk as severity of FMR increases mortality rates range from 15-40 at 1 year Furthermore as the prevalence of heart failure HF is rising FMR is projected to double from over 2 million patients in 2000 to over 4 million patients in the United States by 2030 Defining FMR severity optimal timing of intervention and most appropriate method for intervention remain controversial Recently MITRA-FR and COAPT trials demonstrated contrasting survival benefit with percutaneous MV repair demonstrating the importance and need for more optimal selection criteria Currently the patient selection criteria for Mitraclip therapy are solely based on MV anatomy and controversial echocardiographic criteria for FMR severity Cardiac magnetic resonance CMR provides an exciting opportunity to address numerous unmet needs regarding characterizing FMR and the need for more optimal selection criteria for improving outcomes Superior accuracy and reproducibility for quantification of LV size and function and gold standard tissue characterization positions CMR as the ideal imaging modality for comprehensively characterizing FMR and the underlying myopathic processes that significantly impact response to FMR therapies The goal of the current research is to develop personalized risk prediction for FMR patients through explainable unsupervised phenomapping enriched with advanced CMR imaging biomarkers and to determine the CMR predictors of reverse remodeling following modern therapies for FMR
The proposed research will leverage a large retrospective single center NICM CMR database Our CMR NICM database currently features 458 NICM patients who underwent CMR on a single CMR vendor platform from 2008-2017 who have been extensively curated with contoured data for standard CMR measures An additional 802 NICM patients have been identified from our 2018-2021 CMR database with EF50 with the same inclusionexclusion criteria which will be extensively curated to enable phenomapping discovery An external 400 NICM patient cohort will be used as an external validation cohort
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 with Heart Failure Pharmacist Clinic and followed every 2 weeks until optimized All will return and 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 CMR will be done on dedicated cardiac research MRI scanner
A ischemic cardiomyopathy subgroup will be assessed as a comparator cohort
Prior studies demonstrate significant increases in mortality risk as severity of FMR increases mortality rates range from 15-40 at 1 year Furthermore as the prevalence of heart failure HF is rising FMR is projected to double from over 2 million patients in 2000 to over 4 million patients in the United States by 2030 Defining FMR severity optimal timing of intervention and most appropriate method for intervention remain controversial Recently MITRA-FR and COAPT trials demonstrated contrasting survival benefit with percutaneous MV repair demonstrating the importance and need for more optimal selection criteria Currently the patient selection criteria for Mitraclip therapy are solely based on MV anatomy and controversial echocardiographic criteria for FMR severity Cardiac magnetic resonance CMR provides an exciting opportunity to address numerous unmet needs regarding characterizing FMR and the need for more optimal selection criteria for improving outcomes Superior accuracy and reproducibility for quantification of LV size and function and gold standard tissue characterization positions CMR as the ideal imaging modality for comprehensively characterizing FMR and the underlying myopathic processes that significantly impact response to FMR therapies The goal of the current research is to develop personalized risk prediction for FMR patients through explainable unsupervised phenomapping enriched with advanced CMR imaging biomarkers and to determine the CMR predictors of reverse remodeling following modern therapies for FMR
The proposed research will leverage a large retrospective single center NICM CMR database Our CMR NICM database currently features 458 NICM patients who underwent CMR on a single CMR vendor platform from 2008-2017 who have been extensively curated with contoured data for standard CMR measures An additional 802 NICM patients have been identified from our 2018-2021 CMR database with EF50 with the same inclusionexclusion criteria which will be extensively curated to enable phenomapping discovery An external 400 NICM patient cohort will be used as an external validation cohort
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 with Heart Failure Pharmacist Clinic and followed every 2 weeks until optimized All will return and 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 CMR will be done on dedicated cardiac research MRI scanner
A ischemic cardiomyopathy subgroup will be assessed as a comparator cohort
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01HL170090-01 | NIH | None | httpsreporternihgovquickSearch1R01HL170090-01 |