SterEotactic AbLative Radiotherapy in PatiEnts With HypertrophiC ObstrucTive Cardiomyopathy

NCT ID: NCT04686487

Last Updated: 2022-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-12
• Study Completion Date: 2022-11-01

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.

Conditions

Hypertrophic Obstructive Cardiomyopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stereotactic Ablative Radiotherapy

Stereotactic body radiation therapy delivered to the thick heart muscle at the point of obstruction

Group Type: OTHER

stereotactic ablative radiotherapy

Intervention Type: PROCEDURE

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

Interventions

stereotactic ablative radiotherapy

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Shenghua Zhou

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Countries

China

References

Li X, Zhu Z, Liu J, Gao Y, Xiao Y, Fang Z, Liu Q, Liu X, Hu C, Ma F, Zeng M, Liu Z, Hu L, Liu N, Xiang F, Hu X, Huang L, Zhou S. Septal radioablation therapy for patients with hypertrophic obstructive cardiomyopathy: first-in-human study. Eur Heart J Open. 2023 May 23;3(3):oead052. doi: 10.1093/ehjopen/oead052. eCollection 2023 May.

Reference Type: DERIVED

PMID: 37503357 (View on PubMed)

Other Identifiers

HOCM2018044

Identifier Type: -

Identifier Source: org_study_id