Evaluating Stereotactic Body Radiotherapy for Hypertrophic Obstructive Cardiomyopathy
Safety and Efficacy of Stereotactic Body Radiotherapy in the Treatment of Hypertrophic Obstructive Cardiomyopathy: A Multicenter, Randomized, Single-blind, Controlled Study
This study is testing if a new non-invasive radiation treatment can help people with Hypertrophic Obstructive Cardiomyopathy feel better and reduce their health risks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Second Xiangya Hospital of Central South University Academic / other |
| Locations | 4 sites (Changsha, Hunan and 3 other locations) |
| Trial ID | NCT06167876 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and effectiveness of Stereotactic Body Radiotherapy (SBRT) as a non-invasive treatment for Hypertrophic Obstructive Cardiomyopathy (HOCM). Participants will be randomly assigned to receive either the SBRT treatment or a sham procedure. HOCM is characterized by obstruction of the left ventricular outflow tract, leading to significant health risks. The study seeks to provide an alternative to existing treatments, which may have limitations.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of HOCM and a left ventricular outflow tract pressure gradient of 50mmHg or greater.
Not a fit: Patients with advanced heart failure or those who have previously received invasive treatments for HOCM may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a safer, non-invasive option for patients suffering from HOCM.
How similar studies have performed: Early-stage studies have shown promising results for SBRT in cardiac applications, suggesting potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 years or older. * Confirmed diagnosis of Hypertrophic Obstructive Cardiomyopathy (HOCM) with a left ventricular outflow tract resting pressure gradient of 50mmHg or greater, as evidenced by cardiac ultrasound or Cardiac MRI. * Willingness and consent to undergo non-invasive cardiac radioablation technology for the treatment of HOCM. * Provision of informed consent, indicating voluntary participation in the study. * Capability to read, understand, and communicate in Chinese for study-related procedures and consent. Exclusion Criteria: * Participation in any interventional clinical trial within 30 days prior to enrollment in this study, excluding participation in non-interventional and diagnostic reagent studies. * Previous receipt of any invasive treatment options for HOCM. * Advanced heart failure characterized by NYHA functional class IV. * A left Ventricular Ejection Fraction (LVEF) of less than 30%. * Concurrent severe illnesses that are life-limiting with an expected lifespan of less than one year. * Planned or requirement for any form of surgical intervention. * Pregnancy or currently breastfeeding. * Involvement in the execution or implementation of this study, including study staff and their immediate family members.
Where this trial is running
Changsha, Hunan and 3 other locations
- Hunan Provincial People's Hospital, The First Affiliated Hospital of Hunan Normal University — Changsha, Hunan, China (Recruiting)
- The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)
- The First Affiliated Hospital of University of South China — Hengyang, Hunan, China (Recruiting)
- Xiangtan Central Hospital — Xiangtan, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Shenghua Zhou, M.D.
- Email: zhoushenghua@csu.edu.cn
- Phone: +86 15802609148
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.