Hypertrophic Obstructive Cardiomyopathy
Conditions
Keywords
Hypertrophic Obstructive Cardiomyopathy, Stereotactic Ablative Radiotherapy
Brief summary
Hypertrophic obstructive cardiomyopathy (HOCM) is an inherited myocardial disease which leads to the muscle in the wall of the heart growing and thickening to the point that it blocks blood flow exiting the heart with increasing risk of sudden cardiac death, heart failure, and atrial fibrillation. Surgical septal myectomy and alcohol septal ablation are two invasive therapies for drug-refractory symptomatic patients with HOCM. Unfortunately, some patients may be unsuitable for both the two procedures. Recently, stereotactic ablative radiotherapy, usually used for the treatment of tumours, was confirmed to be feasible, safe and effective in destroying abnormal tissue in heart by targeting high energy heavy ion beams at a specific area of the body precisely. In this study we will determine whether radiation ablation, can be used to destroy the thick heart muscle at the point of obstruction safely and effectively.
Interventions
PROCEDUREstereotactic ablative radiotherapy
stereotactic ablative radiotherapy by targeting high energy heavy ion beams at a specific area of the body
Sponsors
Second Xiangya Hospital of Central South University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female aged ≥ 18 years * Drug-refractory symptomatic patients with HOCM * Willing and able to give written informed consent
Exclusion criteria
* Enrolled in another clinical study. * Patient unable to tolerate lying flat for one hour * Pregnant Or Lactating Women * With other contraindications for receive stereotactic ablative radiotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of stereotactic ablative radiotherapy | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in exercise capacity | 1, 3, 6 and 12 months | 6 minute Walk Test |
| Change in LV wall thickness | 1, 3, 6 and 12 months | Measured on echocardiography |
| Assessment of MACE endpoints | 1, 3, 6 and 12 months | death, heart failure, myocardial infarction and stroke |
| Development of complete heart block, atrial or ventricular arrhythmias | 1, 3, 6 and 12 months | diagnosis by electrocardiogram |
| Change in LVOT gradient | 1, 3, 6 and 12 months | Assessed with transthoracic echocardiography |
Countries
China
Outcome results
None listed