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NCT07865364Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 8 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
50 (estimated)
First submitted
28 Sept 2026
Start date
1 Oct 2026
Primary completion date
Sept 2029
Lead sponsor
Imperial College London
NCT number
NCT07865364

What you commit to

  • Study type: Interventional
  • Planned participants: 50
  • From 1 Oct 2026 to the primary completion date, Sept 2029
  • 8 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Contraindication or intolerance to the required antiplatelet therapy

Other illness

  • Severe renal impairment (Estimated glomerular filtration rate \<30mL/min/1.73m2)
  • Disease modifying drug treatment (mavacamten/aficamten) in past 6 months
  • Obstructive epicardial coronary artery disease, defined as significant angiographic stenosis or physiologically significant disease at investigator discretion

Lab values

  • Left ventricular impairment LVEF \<55%

Age

  • Age \< 18 years

Other

  • Right atrial pressure ≥ 15 mmHg
  • Contraindication to CMR, gadolinium contrast, or adenosine.
  • Implantable cardioverter defibrillator or other device likely to compromise CMR interpretation.
  • Pregnancy
  • Inability to consent

Who the study is looking for

  • Non-obstructive hypertrophic cardiomyopathy (LVOT gradient ≤30 mmHg at rest on echocardiography)
  • Ongoing symptoms despite current medical therapy
  • Significant perfusion defects (≥ 2 myocardial segments) on stress perfusion CMR

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospitals Bristol and Weston NHS Foundation Trust
Coordinator of this site? Confirm its status
BristolUnited KingdomUnknown status
Liverpool Heart and Chest Hospital NHS Foundation Trust
Coordinator of this site? Confirm its status
LiverpoolUnited KingdomUnknown status
Barts Health NHS Trust
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Guy's and St Thomas' NHS Foundation Trust
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Imperial College Healthcare NHS Trust
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Oxford University Hospitals NHS Foundation Trust
Coordinator of this site? Confirm its status
OxfordUnited KingdomUnknown status
University Hospitals Dorset NHS Foundation Trust
Coordinator of this site? Confirm its status
PooleUnited KingdomUnknown status
Mid and South Essex NHS Foundation Trust
Coordinator of this site? Confirm its status
Westcliff-on-SeaUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.