Positron Emission Tomography to Assess the Effect of Camzyos on Ischaemia in HOCM: PEACH Trial

NCT07120776 | Not Yet Recruiting

• 2 other identifiers: IRAS Project ID: 349544REC Reference 25/ES/0044
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Hypertrophic obstructive cardiomyopathy (HOCM) is a heritable heart condition that leads to the thickening of the heart muscle and causes obstruction of blood flow, impeding it's ejection from the heart (LVOT obstruction). Often individuals with HOCM suffer from chest pain and shortness of breath due to lack of oxygen supply (ischaemia) to the heart muscle in the absence of blockages in the coronary arteries. Despite proven advances in treatment of LVOT obstruction with the novel medication Camzyos (Mavacamten), there is a limited understanding of its effect on myocardial ischaemia. This study, called the PEACH Trial, is designed to assess whether Camzyos also improves blood supply (perfusion) to the heart muscle in patients with HOCM. A specialised imaging technique called Positron Emission Tomography/Computed Tomography (PET-CT), using Rubidium-82 will be used to evaluate blood flow to the heart muscle before and after treatment. Camzyos is part of participants' regular clinical treatment and is not being supplied, administered, or influenced by the study in any way. Participants with HOCM who are starting treatment with Camzyos as part of their clinical care will undergo a baseline PET-CT scan (if not already done), and a second scan after 12 months. The follow-up scan is done solely for research purposes. The scans will allow researchers to evaluate whether the medication improves myocardial perfusion in addition to relieving outflow obstruction. The study is sponsored by the University of Manchester and funded by Bristol Myers Squibb. It will involve up to 75 participants recruited at Manchester University NHS Foundation Trust. The findings could help improve understanding of how Camzyos works and support personalised treatment approaches in HOCM.

Conditions

Hypertrophic Obstructive Cardiomyopathy \(HOCM\); Left Ventricular Outflow Tract Obstruction; Myocardial Ischaemia

Keywords

Camzyos; Mavacamten; HOCM; HCM; Cardiac PET; Rubidium-82 PET-CT; Myocardial Perfusion; Nuclear cardiology; Left ventricular outflow obstruction; Cardiomyopathy

Outcome Measures

Primary Outcomes (3)

• Change in Myocardial Ischaemia:

  This will be assessed using Rubidium PET-CT. Looking at change in parameters such as global myocardial blood flow reserve (GMBFR)

  12 months

• Change in Myocardial Ischaemia:

  This will be assessed using Rubidium PET-CT. Looking at change in parameters such as global myocardial stress flow (GMSF).

  12 months

• Change in Myocardial Ischaemia:

  This will be assessed using Rubidium PET-CT. Looking at change in parameters such as coronary flow capacity (CFC).

  12 months

Secondary Outcomes (7)

• Patient-Reported Symptoms

  12 months

• Patient-Reported Symptoms

  12 months

• Patient-Reported Symptoms

  12 months

• Subgroup Analyses

  12 months

• Subgroup Analyses

  12 months

Study Arms (1)

Camzyos (Mavacamten) Treatment Group

EXPERIMENTAL

Patients with Hypertrophic Obstructive Cardiomyopathy (HOCM) who are clinically prescribed Camzyos (Mavacamten) as part of standard care. Participants will undergo baseline(standard care) and 12-month follow-up (research scan) myocardial perfusion PET-CT scans to assess the effect of Camzyos on myocardial ischaemia.

Drug: Camzyos (Mavacamten)

Interventions

Camzyos (Mavacamten) DRUG

Camzyos (Mavacamten), a selective cardiac myosin inhibitor prescribed as part of routine care in patients with symptomatic HOCM. The study evaluates its effect on myocardial perfusion over a 12-month period using PET-CT imaging.

Camzyos (Mavacamten) Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent.
• Aged 18 and over.
• 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.
• Symptoms suggestive of myocardial ischaemia (chest pain, shortness of breath on exertion) with a clinical indication for Rb-PET.
• 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.
• PET-CT performed for clinical reasons at any time in the preceding 18 months if reported as abnormal.

You may not qualify if:

• Contraindications to Mavacamten, including left ventricular ejection fraction (LVEF) less than 55%, hypersensitivity or allergic reaction to the drug.
• Contraindication to Rubidium PET-CT, including:
• Pregnancy or breastfeeding.
• Severe claustrophobia.
• Morbid obesity when the patient dimensions are beyond the scanning chamber capacity.
• 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.

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

Related Publications (1)

• Olivotto I, Oreziak A, Barriales-Villa R, Abraham TP, Masri A, Garcia-Pavia P, Saberi S, Lakdawala NK, Wheeler MT, Owens A, Kubanek M, Wojakowski W, Jensen MK, Gimeno-Blanes J, Afshar K, Myers J, Hegde SM, Solomon SD, Sehnert AJ, Zhang D, Li W, Bhattacharya M, Edelberg JM, Waldman CB, Lester SJ, Wang A, Ho CY, Jacoby D; EXPLORER-HCM study investigators. Mavacamten for treatment of symptomatic obstructive hypertrophic cardiomyopathy (EXPLORER-HCM): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2020 Sep 12;396(10253):759-769. doi: 10.1016/S0140-6736(20)31792-X. Epub 2020 Aug 29.

  PMID: 32871100 BACKGROUND

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic; Ventricular Outflow Obstruction, Left; Coronary Artery Disease; Cardiomyopathies

Interventions

MYK-461

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Andrew Crean, BSc BM MRCP FRCR MPhil MPH

  University of Manchester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tamara Naneishvili, MBBS, MRCP (UK), PhD Student

CONTACT

+447413060202; tamara.naneishvili@manchester.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single-arm prospective cohort study of patients with HOCM undergoing PET imaging before and after Camzyos treatment

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 13, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)