Clinical trial NCT06167876: Safety and Efficacy of Stereotactic Body Radiotherapy in the Treatment of Hypertrophic Obstructive Cardiomyopathy
Official title: Safety and Efficacy of Stereotactic Body Radiotherapy in the Treatment of Hypertrophic Obstructive Cardiomyopathy: A Multicenter, Randomized, Single-blind, Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertrophic Obstructive Cardiomyopathy
Stereotactic Body Radiotherapy
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Change in Left Ventricular Outflow Tract Pressure Gradient under Provoked Conditions
timeFrame: 6 months post-treatment
Secondary outcomes:
measure: Change in Left Ventricular Outflow Tract Pressure Gradient under Resting Conditions
timeFrame: 6 months post-treatment
measure: Impact on NYHA Functional Classification
timeFrame: 6 months post-treatment
measure: Changes in Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores
timeFrame: 6 months post-treatment
measure: Performance in the 6-Minute Walk Test
timeFrame: 6 months post-treatment
measure: Concentration Changes of NT-proBNP and cTNT Post-SBRT Treatment
timeFrame: 6 months post-treatment
measure: Impact on QRS Duration
timeFrame: 6 months post-treatment
measure: Incidence of Major Adverse Cardiac Events (MACEs)
timeFrame: 6 months post-treatment
measure: Monitoring of Serious Adverse Events (SAEs)
timeFrame: Up to 6 months post-treatment
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Provincial People's Hospital, The First Affiliated Hospital of Hunan Normal University
state: Hunan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Hengyang
country: China
facility: The First Affiliated Hospital of University of South China
state: Hunan
city: Xiangtan
country: China
facility: Xiangtan Central Hospital
state: Hunan
Study officials:
References: