Camzyos and heart blood flow in HOCM: a PET imaging study

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The PEACH Trial uses PET-CT imaging to measure heart muscle perfusion before and after starting mavacamten treatment in adults with hypertrophic obstructive cardiomyopathy. Participants receive Camzyos as part of their usual care, and rubidium-82 PET is used to assess changes in blood flow to the heart muscle. The study aims to determine whether reducing LVOT obstruction with mavacamten also improves myocardial perfusion. Results could help clarify how mavacamten affects ischaemia beyond relieving obstruction. The trial is conducted at Manchester University NHS Foundation Trust under the University of Manchester sponsorship.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Written informed consent.
2. Aged 18 and over.
3. Confirmed diagnosis of Hypertrophic Obstructive Cardiomyopathy (HOCM) based on diagnostic criteria, such as unexplained left ventricular hypertrophy with a maximal wall thickness ≥15 mm in the absence of uncontrolled hypertension, valvular heart disease, or HCM phenocopies such as amyloidosis and storage disorders, and presence of either a resting or provoked peak left ventricular outflow tract (LVOT) gradient ≥30 mmHg.
4. Symptoms suggestive of myocardial ischaemia (chest pain, shortness of breath on exertion) with a clinical indication for Rb-PET.
5. Eligible for Mavacamten treatment according to standard clinical guidelines. \[see: https://www.nice.org.uk/guidance/ta913/chapter/1-Recommendations\]. Mavacamten is part of participants' regular clinical treatment and is not being supplied, administered, or influenced by the study in any way.
6. PET-CT performed for clinical reasons at any time in the preceding 5 years, whether reported as normal or abnormal.

Exclusion Criteria:

1. Patients with obstructive coronary artery disease (epicardial coronary stenosis \>50%, assessed by either invasive coronary angiography or computed tomography angiography (CTCA). Patients will undergo the initial PET study as part of their routine clinical care. If evidence of ischaemia is identified, the standard next step would involve either CT coronary angiography or, in some cases, invasive angiography to guide further clinical management. If the angiography reveals a clear lesion responsible for the ischaemia identified on PET, the patient will not be eligible for inclusion in the study and will not be approached. Conversely, if the angiography does not identify a definitive cause for the ischaemia, it will be presumed to be of microvascular origin. In such cases, the patient becomes eligible for the study and will be approached to discuss participation and provide consent at this stage. It is important to emphasize that any angiographic procedure occurs prior to consent and as part of routine clinical care. No angiographic investigations are planned or conducted as part of the study protocol. Data from the clinical angiogram will not be included in the study, except to note a 'positive angiogram' as a reason for patient exclusion.
2. Contraindications to Mavacamten, including left ventricular ejection fraction (LVEF) less than 55%, hypersensitivity or allergic reaction to the drug.
3. Contraindication to Rubidium PET-CT, including:

   * Pregnancy or breastfeeding.
   * Severe claustrophobia.
   * Morbid obesity when the patient dimensions are beyond the scanning chamber capacity.
4. Any medical condition, which in the opinion of the Investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.

Where it's running

• Manchester University NHS Foundation Trust
  Manchester, United Kingdom Recruiting

Study contacts

• Principal investigator: Andrew Crean, BSc BM MRCP FRCR MPhil MPH — University of Manchester
• Study coordinator: Tamara Naneishvili, MBBS, MRCP (UK)
• Email: tamara.naneishvili@manchester.ac.uk
• Phone: +447413060202

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.