RECRUITING

Phenotypic Classification of FMR With CMR

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Improving Phenotypic Classification and Prediction of Treatment Outcomes in Patients With Non-ischemic Cardiomyopathy and Functional Mitral Regurgitation

Quick Facts

Study Start:2023-08-29
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05965258

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. \>moderate aortic regurgitation/stenosis,
  2. 2. \<18 years of age,
  3. 3. acute myocarditis,
  4. 4. eGFR\<15
  5. 5. HCM
  6. 6. cardiac amyloidosis/sarcoidosis
  7. 7. prior mitral valve intervention
  8. 8. myocardial infarction within 8 weeks of CMR

Contacts and Locations

Study Contact

Deborah Kwon, MD
CONTACT
216-444-8526
kwond@ccf.org

Principal Investigator

Deborah Kwon, MD
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

  • Deborah Kwon, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-29
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2023-08-29
Study Completion Date2028-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Nonischemic Congestive Cardiomyopathy
  • Functional Mitral Regurgitation
  • Ischemic Cardiomyopathy