NCT06167876: SAFECARE

Safety and Efficacy of Stereotactic Body Radiotherapy in the Treatment of Hypertrophic Obstructive Cardiomyopathy

Status unknown NA Last updated 19 December 2023

What this trial tests

NA trial testing Stereotactic Body Radiotherapy (SBRT) Treatment in Hypertrophic Obstructive Cardiomyopathy in 36 participants. Status unknown.

Timeline

15 December 2023

Primary endpoint
15 December 2024

15 June 2025

Quick facts

Lead sponsor	Second Xiangya Hospital of Central South University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	36
Start date	15 December 2023
Primary completion	15 December 2024
Estimated completion	15 June 2025
Sites	4 locations across China

Drugs / interventions tested

• Stereotactic Body Radiotherapy (SBRT) Treatment
• Sham Procedure — full drug profile →

Conditions studied

• Hypertrophic Obstructive Cardiomyopathy — all drugs for Hypertrophic Obstructive Cardiomyopathy →
• Stereotactic Body Radiotherapy — all drugs for Stereotactic Body Radiotherapy →

Sponsor

Second Xiangya Hospital of Central South University

Who can join

18 and older, any sex, with Hypertrophic Obstructive Cardiomyopathy or Stereotactic Body Radiotherapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is designed to rigorously evaluate the safety and effectiveness of Stereotactic Body Radiotherapy (SBRT) as an innovative, non-invasive treatment for Hypertrophic Obstructive Cardiomyopathy (HOCM). HOCM, a prevalent cardiac condition, is primarily characterized by asymmetric septal hypertrophy, which results in the obstruction of the left ventricular outflow tract. This obstruction significantly compromises patient quality of life and is associated with severe risks, including arrhythmias and sudden cardiac death. While current treatments like medications, surgical septal myectomy, and percutaneous transluminal septal myocardial ablation (PTSMA) have proven to be effective, they are not without limitations. SBRT, a recent development in non-invasive cardiac radioablation, has shown encouraging results in early-stage studies, suggesting its potential as a safe and feasible option for HOCM treatment.

In this study, participants will be randomly assigned to either the SBRT treatment group or a control group receiving a sham procedure. The primary objective is to measure the change in the left ventricular outflow tract pressure gradient under provoked conditions, using cardiac ultrasound at a 6-month follow-up. This will provide a clear assessment of the direct impact of SBRT on the primary physiological complication of HOCM.

The study also sets forth several secondary objectives to provide a holistic view of the treatment's impact. These include evaluating changes in NYHA functional classification and KCCQ scores to assess improvements in symptom severity and quality of life, respectively. Additionally, we will monitor physical capacity through the 6-minute walk test, and biomarkers like NT-proBNP and cTNT for cardiac stress and damage. The effect of SBRT on QRS duration will be analyzed to understand its impact on cardiac electrical activity. The incidence of major adverse cardiac events (MACEs) within 6 months post-treatment will be recorded to evaluate safety, and the need for invasive septal reduction therapy post-treatment will be assessed to gauge long-term efficacy.

This study aims to provide a comprehensive understanding of the potential of SBRT as a treatment alternative for HOCM. By comparing its outcomes with those of traditional therapies, the study seeks to establish SBRT's role in symptom alleviation, quality of life enhancement, and risk reduction in HOCM management.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.