Hypertrophic Obstructive Cardiomyopathy \(HOCM\)PEACHNCT07120776
Positron Emission Tomography to Assess the Effect of Camzyos on Ischaemia in HOCM: PEACH Trial
A study testing Camzyos (Mavacamten) in people with Hypertrophic Obstructive Cardiomyopathy \(HOCM\) and Left Ventricular Outflow Tract Obstruction, run by University of Manchester at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Obstructive Cardiomyopathy \(HOCM\), Left Ventricular Outflow Tract Obstruction, Myocardial Ischaemia
- What is being tested?
- Camzyos (Mavacamten)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Mar 2026to Oct 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Manchester University NHS Foundation Trust
Manchester, M13 9WL
Tamara Naneishvili, MBBS, MRCP(UK), +447413060202, tamara.naneishvili@manchester.ac.uk
About this study
Official title: Positron Emission Tomography to Assess the Effect of Camzyos on Ischaemia in Hypertrophic Obstructive Cardiomyopathy: The PEACH Trial
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.
Read more
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
- Being tested
- Camzyos (Mavacamten)
- Keywords
- Camzyos, Mavacamten, HOCM, HCM, Cardiac PET, Rubidium-82 PET-CT, Myocardial Perfusion, Nuclear cardiology, Left ventricular outflow obstruction, Cardiomyopathy
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Ventricular Outflow Obstruction, Left, Coronary Artery Disease, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Camzyos (Mavacamten) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: 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).
Measured: 12 months
Secondary outcomes (7)
Patient-Reported Symptoms
Secondary outcomes:
- Patient-Reported Symptoms:
- Angina and Shortness of Breath: Changes in the frequency and severity of angina episodes and shortness of breath will be documented using validated the Seattle Angina Questionnaire- 7 (SAQ).
Seattle Angina Questionnaire-7 (SAQ-7, 2014 version):
The SAQ-7 is a validated, patient-reported outcome measure assessing the impact of angina on health status. It consists of 7 items covering 3 domains: Physical Limitation, Angina Frequency, and Quality of Life. Each domain is scored on a 0-100 scale, where higher scores indicate better health status (less angina, fewer physical limitations, and improved quality of life). Scores are transformed according to published scoring algorithms. The SAQ-7 Summary Score is the mean of the 3 domain scores.
Minimum score: 0 (worst possible angina-related health status) Maximum score: 100 (no angina, no limitation, best possible quality of life)
Measured: 12 months
Patient-Reported Symptoms
Secondary outcomes:
- Patient-Reported Symptoms:
- Angina and Shortness of Breath: Changes in the frequency and severity of angina episodes and shortness of breath will be documented using validated the the HCM Shortness of Breath Questionnaire (HCMSQ-SoB) (also used in the EXPLORER-HCM trial)
- The HCMSQ total score is as the equally weighted sum of the three domain scores, i.e., the sum of the SoB domain score divided by four (items), the tiredness domain score (a single item), and the CV symptom domain score divided by three (items), if all three domain scores are calculated; otherwise, the HCMSQ total score is missing. The potential range of scores is 0-12.5, with lower scores indicating a lower presence of symptoms overall/better health.
Measured: 12 months
Patient-Reported Symptoms
Secondary outcomes:
NYHA Functional Class: Improvement in NYHA functional class will be evaluated to assess changes in functional capacity and symptom severity.
New York Heart Association (NYHA) Functional Classification - Ordinal scale ranging from Class I (no symptoms and no limitation in ordinary physical activity) to Class IV (severe limitations; symptoms present even at rest). Lower classes indicate better functional status, and improvement is reflected by a decrease in NYHA class from baseline.
Measured: 12 months
Subgroup Analyses
Differences in Efficacy Based on Patient Subgroups:
- Subgroup Analyses: The study will investigate differences in the impact of Mavacamten on myocardial ischemia and symptoms based on:
- Age years (younger vs. older patients)
Measured: 12 months
Subgroup Analyses
Differences in Efficacy Based on Patient Subgroups:
- Subgroup Analyses: The study will investigate differences in the impact of Mavacamten on myocardial ischemia and symptoms based on:
- Sex (male vs. female)
Measured: 12 months
Subgroup Analyses
Differences in Efficacy Based on Patient Subgroups:
- Subgroup Analyses: The study will investigate differences in the impact of Mavacamten on myocardial ischemia and symptoms based on:
- Genetic Status (gene-positive vs. gene-negative vs VUS)
Measured: 12 months
Subgroup Analyses
Differences in Efficacy Based on Patient Subgroups:
- Subgroup Analyses: The study will investigate differences in the impact of Mavacamten on myocardial ischemia and symptoms based on:
- Baseline LVOT Gradient Levels (mmHg) (higher vs. lower LVOT gradients)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start26 Mar 2026
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertrophic Obstructive Cardiomyopathy \(HOCM\)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm prospective cohort study of patients with HOCM undergoing PET imaging before and after Camzyos treatment
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Crean, University of Manchester
- Investigators
- Andrew Crean, BSc BM MRCP FRCR MPhil MPH, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120776
- Sponsor's protocol ID
- IRAS Project ID: 349544
- Other IDs
- REC Reference 25/ES/0044
- Acronym
- PEACH
- Status last verified
- May 2026
- First submitted
- 1 Aug 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data access is limited to the research team as per ethical and institutional approvals.
Publications
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.
PubMed 32871100