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Coronary Sinus Reducer Objective Impact on SymptoMs, Ischaemia and miCrovascular Resistance in Non-obstructive Hypertrophic CardioMyopathy

Study acronym: COSMIC-HCM
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Hypertrophic cardiomyopathy (HCM) is a common heart condition in which the heart muscle becomes abnormally thick. In non-obstructive HCM, blood flow out of the heart is not blocked, but many patients still experience chest pain, breathlessness and limitation of daily activities. This may be because the small blood vessels within the thickened heart muscle do not supply enough blood and oxygen, particularly during exercise or stress. Current treatment options for symptomatic non-obstructive HCM are limited. This study will test a small device called the coronary sinus reducer (CSR), which is placed into a vein of the heart using a catheter. The CSR is designed to improve blood flow to areas of heart muscle that are short of blood supply. Fifty adults with non-obstructive HCM, ongoing symptoms and reduced blood supply on a heart MRI scan will take part. Participants will be randomly assigned to receive either CSR implantation or a placebo procedure. Neither participants nor the follow-up research team will know which procedure was performed until the 6-month follow-up assessments are complete. The investigators will use detailed heart MRI scans to measure blood flow, a smartphone app to record daily symptoms, coronary sinus blood tests to look for biochemical evidence of reduced oxygen supply, and invasive coronary physiology measurements to assess the small blood vessels of the heart. The main aim is to find out whether the CSR improves blood flow and reduces symptoms. The results may identify a new treatment option for patients with non-obstructive HCM and improve understanding of the disease.
Trial Details
NCT Number NCT07865364
Lead Sponsor Imperial College London
Conditions Hypertrophic Cardiomyopathy
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov