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New treatment option for Hypertrophic Obstructive Cardiomyopathy \(HOCM\)
Official title Positron Emission Tomography to Assess the Effect of Camzyos on Ischaemia in HOCM: PEACH Trial
ClinicalTrials.gov ID: NCT07120776
What this study is testing
What is Camzyos (Mavacamten)?
Camzyos (Mavacamten) is an investigational medicine, being studied as a potential treatment for hypertrophic obstructive cardiomyopathy \(hocm\).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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]...
You likely can't join if
- Patients with obstructive coronary artery disease (epicardial coronary stenosis \>50%, assessed by either invasive coronary angiography or computed...
- 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.
See the full eligibility criteria
- 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...
- 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...
- PET-CT performed for clinical reasons at any time in the preceding 18 months if reported as abnormal.
- 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...
- 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 team makes the final eligibility decision.
Where it's taking place
- Manchester, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Manchester, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.