SterEotactic AbLative Radiotherapy in PatiEnts With HypertrophiC ObstrucTive Cardiomyopathy (SELECT)

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertrophic Obstructive Cardiomyopathy
• Intervention / Treatment: Procedure: stereotactic ablative radiotherapy

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410011
      • The Second Xiangya Hospital of Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Second Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2021
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: December 15, 2020
• First Submitted That Met QC Criteria: December 23, 2020
• First Posted (Actual): December 28, 2020

Study Record Updates

• Last Update Posted (Actual): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Hypertrophic Obstructive Cardiomyopathy; Stereotactic Ablative Radiotherapy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Hypertrophy; Cardiomyopathies; Cardiomyopathy, Hypertrophic
• Other Study ID Numbers: HOCM2018044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No