Safety and Efficacy of Stereotactic Body Radiotherapy in the Treatment of Hypertrophic Obstructive Cardiomyopathy
NCT ID: NCT06167876
Last Updated: 2023-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
36 participants
INTERVENTIONAL
2023-12-15
2025-06-15
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Stereotactic Body Radiotherapy (SBRT) Treatment Group
This arm of the study encompasses patients who are receiving the non-invasive Stereotactic Body Radiotherapy (SBRT) as the primary treatment for Hypertrophic Obstructive Cardiomyopathy (HOCM). The group will undergo precise imaging-guided radiotherapy targeting the interventricular septum, avoiding critical cardiac structures, and delivering a single high-dose radiation treatment with the aim of alleviating the symptoms of HOCM and improving cardiac function.
Stereotactic Body Radiotherapy (SBRT) Treatment
The intervention in this study utilizes Stereotactic Body Radiotherapy (SBRT) for treating Hypertrophic Obstructive Cardiomyopathy (HOCM). The process begins with precise localization and planning, employing CT scans, Cardiac MRI (CMR), and echocardiography to accurately identify the target area in the interventricular septum, while avoiding critical structures like the aortic valve, His bundle, and left ventricular papillary muscles. Pre-treatment preparation involves using customized fixation devices to limit patient movement and breathing, coupled with cone-beam CT scans for accurate alignment with the Treatment Planning System (TPS). The treatment itself is delivered using image-guided linear accelerators, administering a single, focused dose of 25 Gy to the targeted area. This approach ensures precise radiation delivery, maximizing treatment efficacy while minimizing risks to surrounding cardiac tissues.
Sham Procedure Control Group
Participants in this arm will undergo a sham procedure, which mimics the SBRT treatment process without actual radiation delivery. This group serves as a control to assess the efficacy and safety of the SBRT treatment by providing a comparative baseline. The sham procedure involves aligning patients with the linear accelerator and replicating the treatment environment, including equipment sounds and lighting, without administering any radiation.
Sham Procedure
The sham procedure in this study is designed to closely mimic the actual Stereotactic Body Radiotherapy (SBRT) process without delivering any radiation. Participants in this arm are subjected to the same initial steps as those in the SBRT group, including precise alignment with the linear accelerator using CT scans and the application of customized fixation devices to limit movement and breathing. However, in this sham intervention, the linear accelerator is activated but does not emit any radiation. The procedure replicates the environmental aspects of the actual treatment, such as the equipment's sounds and lighting, to maintain the study's single-blind nature. This method ensures that participants in the sham group experience a procedure identical in appearance and feel to the SBRT treatment, without receiving any therapeutic dose, thereby serving as an effective control for evaluating the true impact of SBRT in treating HOCM.
Interventions
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Stereotactic Body Radiotherapy (SBRT) Treatment
The intervention in this study utilizes Stereotactic Body Radiotherapy (SBRT) for treating Hypertrophic Obstructive Cardiomyopathy (HOCM). The process begins with precise localization and planning, employing CT scans, Cardiac MRI (CMR), and echocardiography to accurately identify the target area in the interventricular septum, while avoiding critical structures like the aortic valve, His bundle, and left ventricular papillary muscles. Pre-treatment preparation involves using customized fixation devices to limit patient movement and breathing, coupled with cone-beam CT scans for accurate alignment with the Treatment Planning System (TPS). The treatment itself is delivered using image-guided linear accelerators, administering a single, focused dose of 25 Gy to the targeted area. This approach ensures precise radiation delivery, maximizing treatment efficacy while minimizing risks to surrounding cardiac tissues.
Sham Procedure
The sham procedure in this study is designed to closely mimic the actual Stereotactic Body Radiotherapy (SBRT) process without delivering any radiation. Participants in this arm are subjected to the same initial steps as those in the SBRT group, including precise alignment with the linear accelerator using CT scans and the application of customized fixation devices to limit movement and breathing. However, in this sham intervention, the linear accelerator is activated but does not emit any radiation. The procedure replicates the environmental aspects of the actual treatment, such as the equipment's sounds and lighting, to maintain the study's single-blind nature. This method ensures that participants in the sham group experience a procedure identical in appearance and feel to the SBRT treatment, without receiving any therapeutic dose, thereby serving as an effective control for evaluating the true impact of SBRT in treating HOCM.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Second Xiangya Hospital of Central South University
OTHER
Responsible Party
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Shenghua Zhou
Professor
Locations
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Hunan Provincial People's Hospital, The First Affiliated Hospital of Hunan Normal University
Changsha, Hunan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China
Xiangtan Central Hospital
Xiangtan, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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Hongwei Pan, Ph.D.
Role: primary
Shenghua Zhou
Role: primary
Huifang Tang, Ph.D.
Role: primary
Jianping Zeng, M.D.
Role: primary
Other Identifiers
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LYG20230056
Identifier Type: -
Identifier Source: org_study_id