SterEotactic AbLative Radiotherapy in PatiEnts With HypertrophiC ObstrucTive Cardiomyopathy

Hypertrophic Obstructive Cardiomyopathy Clinical Trial

— SELECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04686487
• Other study ID #: HOCM2018044
• Status: Completed
• Phase: N/A
• Start date: January 12, 2021
• Est. completion date: November 1, 2022

Study information

• Verified date: November 2022
• Source: Second Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: November 1, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Obstructive Cardiomyopathy
• Hypertrophy

Intervention

Procedure:
• stereotactic ablative radiotherapy
stereotactic ablative radiotherapy by targeting high energy heavy ion beams at a specific area of the body

Locations

Country	Name	City	State
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Second Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

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