SterEotactic AbLative Radiotherapy in PatiEnts With HypertrophiC ObstrucTive Cardiomyopathy

Study Overview
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Brief Summary
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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.

Official Title
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Stereotactic Ablative Radiotherapy in Patients With Hypertrophic Obstructive Cardiomyopathy: First in Man Pilot Study

Conditions
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Hypertrophic Obstructive Cardiomyopathy

Intervention / Treatment
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* Procedure: stereotactic ablative radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Stereotactic Ablative Radiotherapy<br>Stereotactic body radiation therapy delivered to the thick heart muscle at the point of obstruction | Procedure: stereotactic ablative radiotherapy<br>* stereotactic ablative radiotherapy by targeting high energy heavy ion beams at a specific area of the body<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of stereotactic ablative radiotherapy | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of MACE endpoints | death, heart failure, myocardial infarction and stroke | 1, 3, 6 and 12 months | 
| Development of complete heart block, atrial or ventricular arrhythmias | diagnosis by electrocardiogram | 1, 3, 6 and 12 months | 
| Change in LVOT gradient | Assessed with transthoracic echocardiography | 1, 3, 6 and 12 months | 
| Change in exercise capacity | 6 minute Walk Test | 1, 3, 6 and 12 months | 
| Change in LV wall thickness | Measured on echocardiography | 1, 3, 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertrophic Obstructive Cardiomyopathy, Stereotactic Ablative Radiotherapy