Functional Mitral Regurgitation, Heart Failure and Reduced Ejection Fraction
Conditions
Keywords
heart failure, reduced ejection fraction, functional mitral regurgitation
Brief summary
This is a multi-center, prospective, observational study designed to evaluate the impact of LV myocardial fibrosis extent assessed by CMR on LV reverse remodeling and clinical outcomes post TEER. The target sample will be up to 125 patients enrolled to achieve 100 evaluable at 6 months of follow-up. Enrollment will occur at up to eight centers.
Detailed description
Patients undergoing guideline-directed TEER with FDA-approved MitraClip at the participating centers will be screened and recruited for study participation. After informed consent is obtained, patients will undergo a clinically-indicated baseline CMR study with gadolinium up to 90 days before TEER procedure. In addition, a quality-of-life surveillance questionnaire (KCCQ) will be completed at the same baseline visit. Six months after TEER patients will return to clinic to repeat the quality of life surveillance questionnaire (KCCQ), the CMR study and a transthoracic echocardiogram. The 6-month CMR study and echocardiogram should be completed on the same day or no greater than 30 days apart if the same day is not feasible. Blood samples will be collected on the day of the CMR to provide the hematocrit for ECV calculation. These samples are done as standard clinical care. Electronic Health Records (EHR) will be reviewed and phone contact performed yearly for up to three years after TEER to evaluate clinical outcomes (heart failure hospitalization, outpatient use of intravenous inotropes, LVAD implant, heart transplant, or death).
Interventions
DIAGNOSTIC_TESTCardiac MRI
Clinically indicated baseline CMR study with contrast up to 90 days before TEER procedure, including KCCQ questionnaire. At 6 months, participants will return for repeat of KCCQ, CMR study and a transthoracic echocardiogram. Blood samples, done as standard clinical care for hemotocrit for ECV calculation, will be obtained.
Sponsors
Minneapolis Heart Institute Foundation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\. Adult patients (≥ 18 years old) with heart failure and reduced ejection fraction (LVEF \< 50% defined by echocardiography), medically and device-optimized according to guidelines, with significant FMR undergoing TEER with FDA-approved MitraClip device (Abbott Structural, USA)
Exclusion criteria
1. Concomitant PCI and TEER 2. Congenital heart disease 3. Stage D heart failure 4. Uncontrolled atrial fibrillation 5. Pregnancy 6. \> moderate tricuspid regurgitation 7. \>moderate aortic regurgitation or stenosis 8. Contraindications or unable to undergo CMR 9. Prior mitral valve repair or replacement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimate the association between LV myocardial fibrosis by CMR late gadolinium enhancement imaging before TEER with LV reverse remodeling. | From enrollment to the end of 6 months | change in LV end-diastolic volume index \[LVEDVi\] 6 months after TEER |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimate the association of LV myocardial fibrosis extent and a combined endpoint including all-cause death, heart failure hospitalization, cardiac transplant and LVAD implant; | Enrollment to the end of 6 months | LV myocardial fibrosis and endpoint data points (all cause death, heart failure hospitalization, cardiac transplant and LVAD implant) |
| Estimate the association of the ratio between CMR-based mitral regurgitant volume (RegVol) and LV end-diastolic volume (LVEDV)-RegVol/LVEDV-with LV reverse remodeling; | Enrollment to the end of 6 months | Reg/Vol and LVEDV with LV reverse remodeling |
| Estimate the association between LV extracellular volume (ECV) by CMR T1 mapping before TEER with LV reverse remodeling | Enrollment to the end of 6 months | ECV before TEER with LV reverse remodeling |
| Estimate the association of LV myocardial fibrosis extent and the change in quality-of-life (Kansas City Cardiomyopathy Questionnaire [KCCQ]) post TEER | Enrollment to the end of 6 months | LV myocardial extent and % of change in quality of life KCCQ |
| Estimate the intermodality agreement of residual MR between 3D echo and CMR at 6 months post-TEER | Enrollment through 6 months | Intermodality agreement of residential agreement in echo and CMR |
| Evaluate the interaction between CMR-based mitral regurgitation quantification (RegVol and regurgitant fraction) with LV myocardial fibrosis extent, and its association with LV reverse remodeling | Enrollment to the end of 6 months | RegVol and regurgitant fraction with LV myocardial fibrosis extent |
Countries
Italy, United States
Contacts
Primary ContactJoão Cavalcante, MD
Backup ContactSarah Schwager, RN
Outcome results
None listed