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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Stereotactic body radiation therapy delivered to reduce LVOTO in patients with HCM
Barts Heart Centre
London, United Kingdom
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.
Time frame: 90 days
Assessment of MACE endpoints
MACE = death, heart failure, myocardial infarction and stroke
Time frame: 3, 6 and 12 months
Change in aortic valve and mitral valve function
Echocardiography assessed aortic and mitral valve function
Time frame: 3, 6 and 12 months
Left anterior descending artery patency
Patency of left anterior descending artery with cardiac CT
Time frame: 12 months
Presence of radiation pneumonitis
Presence of radiation pneumonitis on CT
Time frame: 12 months
Development of complete heart block, atrial or ventricular arrhythmias
Cardiac device (ICD or pacemaker) check
Time frame: 3, 6 and 12 months
Change in LVOT gradient
Assessed with transthoracic echocardiography using same loading conditions as baseline
Time frame: 3, 6 and 12 months
Change in functional class
Change in NYHA and CCS class from baseline
Time frame: 6 and 12 months
Change in frequency of syncope and pre-syncope
Baseline to 6 and 12 months
Time frame: 6 and 12 months
Change in exercise capacity
6 minute Walk Test
Time frame: 6 and 12 months compared to Baseline
Change in health status
EQ-5D-5L
Time frame: 6 and 12 months compared to Baseline
Troponin T elevation
Measurement of Trop T
Time frame: 1,2,3 days post ablation
Change in LV wall thickness
CMR assessed thickness
Time frame: 6 months
Left ventricular ejection fraction (LVEF)
Measured on echocardiography
Time frame: 3, 6 and 12 months
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