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

Launched by SECOND XIANGYA HOSPITAL OF CENTRAL SOUTH UNIVERSITY · Dec 11, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Stereotactic Body Radiotherapy (SBRT) for people with Hypertrophic Obstructive Cardiomyopathy (HOCM), a heart condition that causes a thickening of the heart muscle, which can block blood flow and lead to serious problems. The goal is to see if SBRT can safely improve heart function and the quality of life for patients suffering from this condition. Participants will be randomly placed in either the SBRT group or a control group receiving a fake treatment. Researchers will monitor changes in heart pressure and other health measures over six months to evaluate the treatment's effectiveness.

To be eligible for the trial, participants must be adults aged 18 or older with a confirmed diagnosis of HOCM and a specific level of heart pressure. They should also be willing to undergo this non-invasive treatment. Throughout the study, participants can expect regular check-ups, including heart ultrasounds and tests to assess their symptoms and overall health. This trial aims to provide valuable insights into whether SBRT can be a safe and effective alternative to traditional treatments for HOCM, potentially helping many patients improve their health and well-being.

Gender

ALL

Eligibility 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.