Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Barts Cardiovascular CTU (Queen Mary University of London) | UNKNOWN |
| Barts Clinical Trial Unit | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic body radiation therapy | Experimental | In patients with HCM and refractory symptoms from LVOTO, stereotactic body radiation therapy will be delivered locally to relieve symptoms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic body radiation therapy | Device | Stereotactic body radiation therapy delivered to reduce LVOTO in patients with HCM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrate acute (≤ 90 days) safety of non-invasive SBRT. | The primary safety endpoint is defined as serious adverse events (SAEs) that are possibly/probably/definitely related to study treatment, based on previously published data for expected invasive alcohol septal-ablation procedures. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of MACE endpoints | MACE = death, heart failure, myocardial infarction and stroke | 3, 6 and 12 months |
| Change in aortic valve and mitral valve function | Echocardiography assessed aortic and mitral valve function |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Costas O'Mahony, FRCP, MD | Barts & The London NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barts Heart Centre | London | EC1A 7BE | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
Not provided
Not provided
| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 3, 6 and 12 months |
| Left anterior descending artery patency | Patency of left anterior descending artery with cardiac CT | 12 months |
| Presence of radiation pneumonitis | Presence of radiation pneumonitis on CT | 12 months |
| Development of complete heart block, atrial or ventricular arrhythmias | Cardiac device (ICD or pacemaker) check | 3, 6 and 12 months |
| Change in LVOT gradient | Assessed with transthoracic echocardiography using same loading conditions as baseline | 3, 6 and 12 months |
| Change in functional class | Change in NYHA and CCS class from baseline | 6 and 12 months |
| Change in frequency of syncope and pre-syncope | Baseline to 6 and 12 months | 6 and 12 months |
| Change in exercise capacity | 6 minute Walk Test | 6 and 12 months compared to Baseline |
| Change in health status | EQ-5D-5L | 6 and 12 months compared to Baseline |
| Troponin T elevation | Measurement of Trop T | 1,2,3 days post ablation |
| Change in LV wall thickness | CMR assessed thickness | 6 months |
| Left ventricular ejection fraction (LVEF) | Measured on echocardiography | 3, 6 and 12 months |
| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |