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Clinical Trial of a MEK Inhibitor for RASopathy-Associated Severe Infantile Hypertrophic Cardiomyopathy: Baby MERIT

Study acronym: Baby MERIT
StatusNot Yet Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
Carelon Research
8 trials monitored
See 2 trials at risk
Heart Disease
8,786 trials monitored
See 412 trials at risk
Heart Failure
1,995 trials monitored
See 111 trials at risk
This project seeks to perform a Phase 3 clinical trial to test whether an FDA-approved cancer drug called trametinib is effective in treating young infants with genetic conditions called RASopathies and a severe, life-threatening heart problem called hypertrophic cardiomyopathy. The purpose of this research is to demonstrate that trametinib is effective in preventing these sick babies from dying, receiving a heart transplant or undergoing heart surgery to remove extra heart muscle over a one-year period. In addition, the investigators will determine how often this heart problem comes back when the trametinib treatment is stopped.
Trial Details
NCT Number NCT07817186
Lead Sponsor Carelon Research
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)		 HCM, Noonan Syndrome and Other Rasopathy, Heart Failure (Pediatric)
Related terms Heart Failure, Noonan Syndrome
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov