SterEotactic AbLative Radiotherapy in PatiEnts With HypertrophiC ObstrucTive Cardiomyopathy

Not Applicable

Completed

• Conditions: Hypertrophic Obstructive Cardiomyopathy
• Interventions: Procedure: stereotactic ablative radiotherapy

• Registration Number: NCT04686487
• Lead Sponsor: Second Xiangya Hospital of Central South University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-15
• Study First Submitted QC: 2020-12-23
• Study First Posted: 2020-12-28
• Study Start: 2021-01-12
• Primary Completion: 2022-04-30
• Status Verified: 2022-11
• Study Completion: 2022-11-01
• Last Update Submitted: 2022-11-28
• Last Update Posted: 2022-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stereotactic Ablative Radiotherapy	stereotactic ablative radiotherapy	Stereotactic body radiation therapy delivered to the thick heart muscle at the point of obstruction

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

The Second Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China