COSMIC-HCM
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · British Heart Foundation
interventional
50
1 country
8
Study Start
October 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 28, 2026
Actual (reported)October 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 8, 2026
Actual (reported)September 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Daily symptom frequency during blinded 6-month follow-up
Patient-reported. ORBITA-app daily symptom reporting.
During blinded 6-month follow-up
The change in ratio of stress MBF in ischaemic versus non-ischaemic myocardial subsegments at 6 months comparing CSR and placebo groups
Quantitative stress perfusion CMR.
Baseline and 6 months
Coronary sinus lactate concentration during adenosine stress
Randomisation procedure
Coronary sinus pH during adenosine stress
Randomisation procedure
MacNew Heart Disease Health-related Quality of Life Questionnaire
Baseline and 6-month follow-up
Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS)
Baseline and 6-month follow-up
EQ-5D-5L
Baseline and 6-month follow-up
Stress myocardial blood flow (MBF) in ischaemic, non-ischaemic myocardial segments, and globally
Baseline and 6-month follow-up
Rest myocardial blood flow (MBF) in ischaemic, non-ischaemic myocardial segments, and globally
Baseline and 6-month follow-up
Myocardial perfusion reserve (MPR) in ischaemic, non-ischaemic myocardial segments, and globally
Baseline and 6-month follow-up
Participants allocated to CSR will have the device implanted into the coronary sinus.
Participants in the placebo group will not have the device implanted, but will remain sedated in the catheter laboratory for 15-30 minutes so that the experience is similar and blinding is maintained.
The Shockwave Reducer (coronary sinus reducer) is intended to create a controlled narrowing that increases coronary sinus pressure and redistributes venous blood flow from epicardial to subendocardial regions, thereby improving myocardial perfusion in areas of microvascular ischaemia.
University Hospitals Bristol and Weston Nhs Foundation Trust
Bristol, BS1 3NU, United Kingdom
Liverpool Heart and Chest Hospital Nhs Foundation Trust
Liverpool, L14 3PE, United Kingdom
Barts Health Nhs Trust
London, E1 2ES, United Kingdom
First Submitted
September 28, 2026
First Posted
October 8, 2026
Study Start
Participants in the placebo group will not have the device implanted, but will remain sedated in the catheter laboratory for 15-30 minutes so that the experience is similar and blinding is maintained.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Guy'S and St Thomas' Nhs Foundation Trust
London, SE1 7EH, United Kingdom
Imperial College Healthcare NHS Trust
London, W2 1BL, United Kingdom
Oxford University Hospitals Nhs Foundation Trust
Oxford, OX3 9DU, United Kingdom
University Hospitals Dorset Nhs Foundation Trust
Poole, BH15 2JB, United Kingdom
Mid and South Essex Nhs Foundation Trust
Westcliff-on-Sea, SS0 0RY, United Kingdom
October 1, 2026
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 8, 2026
Record last verified: 2026-09
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