SterEotactic AbLative Radiotherapy in PatiEnts With HypertrophiC ObstrucTive Cardiomyopathy

NCT04686487 | Completed DMC

• 1 other identifier: HOCM2018044
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Keywords

Hypertrophic Obstructive Cardiomyopathy; Stereotactic Ablative Radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Assessment of MACE endpoints

  1, 3, 6 and 12 months

• Development of complete heart block, atrial or ventricular arrhythmias

  1, 3, 6 and 12 months

• Change in LVOT gradient

  1, 3, 6 and 12 months

• Change in exercise capacity

  1, 3, 6 and 12 months

• Change in LV wall thickness

  1, 3, 6 and 12 months

Study Arms (1)

Stereotactic Ablative Radiotherapy

OTHER

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

Procedure: stereotactic ablative radiotherapy

Interventions

stereotactic ablative radiotherapy PROCEDURE

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

Stereotactic Ablative Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged ≥ 18 years
• Drug-refractory symptomatic patients with HOCM
• Willing and able to give written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead

Study Sites (1)

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

Related Publications (1)

• 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.

  PMID: 37503357 DERIVED

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 28, 2020
• Study Start: January 12, 2021
• Primary Completion: April 30, 2022
• Study Completion: November 1, 2022
• Last Updated: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)