NCT04153162Completed
Non-Invasive Radiation Ablation in Patients With Hypertrophic CardioMyopathy: NIRA-HOCM
Non-Invasive Radiation Ablation for Septal Reduction in Patients With Hypertrophic Obstructive CardioMyopathy: First in Man Pilot Study
Source: ClinicalTrials.gov · Last updated 17 Mar 2025
Brief summary (registry, in English)
Hypertrophic cardiomyopathy (HCM) is a common disease of the heart which causes thickening of the heart muscle. HCM primarily affects the muscle of the main pumping chamber of the heart (the left ventricle) and particularly the septum (this is the muscular wall which separates the right and left side of the heart). In a subgroup of patients, the thickened heart muscle at the septum prevents blood from leaving the heart during contraction (this is called obstruction). This form of the disease is called hypertrophic obstructive cardiomyopathy (HOCM). HOCM is a common cause of shortness of breath, chest pain and dizzy spells. These symptoms are treated with tablets and if symptoms are uncontrolled, patients are often offered invasive treatment to get rid of some of the thick heart muscle and reduce obstruction. This is achieved either by: 1. open heart surgery (myectomy) where a surgeon cuts out the thick muscle 2. injection of alcohol to the thick heart muscle via a tube in the wrist or groin (alcohol septal ablation). The alcohol thins the heart muscle at the point of obstruction, mimicking the effects of myectomy. Unfortunately, some patients are not suitable for both these procedures. This study will test whether radiotherapy, usually used for the treatment of tumours, can be used to destroy the thick heart muscle at the point of obstruction safely and effectively. Study patients will be monitored following the procedure and the investigators plan to measure the levels of heart muscle thinning, reduction of obstruction and improvement in symptoms and importantly document any side effects. Radiotherapy works by precisely targeting high energy X-rays (ionising radiation) at a specific area of the body with the aim of destroying abnormal tissue. CyberKnife is one of the latest radiotherapy delivery systems, which will deliver highly focussed and accurate radiotherapy.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 1 (actual)
- First submitted
- 4 Nov 2019
- Start date
- Jan 2020
- Primary completion date
- Jan 2025
- Lead sponsor
- Barts & The London NHS Trust
- Diseases
- Hypertrophic cardiomyopathy
- NCT number
- NCT04153162
What you commit to
- Study type: Interventional
- Participants enrolled: 1
- From Jan 2020 to the primary completion date, Jan 2025
- 1 site 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
- Previous chest radiotherapy
Other illness
- New York Heart Association I-II
- Lack of cardiac device with anti-bradycardia pacing capabilities
Other
- Canadian Cardiovascular Society class 1-2
- Follow-up impossible (e.g. no fixed abode)
- Weight of patient that exceeds the maximum limit of CMR table (170kg)
- Subjects of childbearing potential unless βHCG negative and on contraception
- Inability to provide informed consent.
Who the study is looking for
- Limiting, drug refractory symptoms secondary to left ventricular outflow tract obstruction
- Previously failed invasive septal reduction therapy (ethanol septal ablation/surgical myectomy) or inability to perform invasive septal reduction due to increased risk/co-morbidities/anatomical considerations following specialist MDT review
- A device (permanent pacemaker or implantable cardioverter defibrillator) in situ.
- Ventricular septal thickness at site ablation ≥ 16mm.
- Patient able to tolerate lying flat for one hour
- High target-surrogacy of ICD/pacing lead for cardiac motion (from cardiac-gated MRI or cardiac-gated CT with the patient in pacing mode used for treatment)
- Successful completion of ICD lead tip tracking test ("patient dummy run") with the patient in pacing mode used for treatment
- Adult Patients aged 18 and over willing and able to give written informed consent
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Barts Heart Centre Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.