Hypertrophic Obstructive CardiomyopathySAFECARENCT06167876
Safety and Efficacy of Stereotactic Body Radiotherapy in the Treatment of Hypertrophic Obstructive Cardiomyopathy
A study testing Stereotactic Body Radiotherapy (SBRT) Treatment in people with Hypertrophic Obstructive Cardiomyopathy and Stereotactic Body Radiotherapy, run by Second Xiangya Hospital of Central South University at 4 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Obstructive Cardiomyopathy, Stereotactic Body Radiotherapy
- What is being tested?
- Stereotactic Body Radiotherapy (SBRT) Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 4 sitesChina
- Study dates
- 15 Dec 2023to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Hunan Provincial People's Hospital, The First Affiliated Hospital of Hunan Normal University
Changsha, Hunan, 410005
Hongwei Pan, Ph.D., +86 13487311869, 474282550@qq.com
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Shenghua Zhou, +86 15802609148, zhoushenghua@csu.edu.cn
- Recruiting
The First Affiliated Hospital of University of South China
Hengyang, Hunan, 421001
Huifang Tang, Ph.D., +86 13548505158, tanghuifang999@163.com
- Recruiting
Xiangtan Central Hospital
Xiangtan, Hunan, 411413
Jianping Zeng, M.D., +86 13973206628, zengjp88@163.com
About this study
Official title: Safety and Efficacy of Stereotactic Body Radiotherapy in the Treatment of Hypertrophic Obstructive Cardiomyopathy: A Multicenter, Randomized, Single-blind, Controlled Study
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.
Read more
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.
- Being tested
- Stereotactic Body Radiotherapy (SBRT) Treatment, Sham Procedure
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiotherapy (SBRT) TreatmentRadiation
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 ProcedureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Body Radiotherapy (SBRT) Treatment Group | Experimental | 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. Receives: Radiation: Stereotactic Body Radiotherapy (SBRT) Treatment |
| Sham Procedure Control Group | Sham comparator | 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. Receives: Other: Sham Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Left Ventricular Outflow Tract Pressure Gradient under Provoked Conditions
This primary outcome measure evaluates the effectiveness of non-invasive radiotherapy (SBRT) in altering the left ventricular outflow tract pressure gradient under provoked conditions in patients with Hypertrophic Obstructive Cardiomyopathy (HOCM). The measurement is determined using cardiac ultrasound, assessing the extent to which SBRT can alleviate the obstruction in the heart's outflow tract, a key indicator of therapeutic success in HOCM treatment.
Measured: 6 months post-treatment
Secondary outcomes (8)
Change in Left Ventricular Outflow Tract Pressure Gradient under Resting Conditions
This measure assesses the change in the left ventricular outflow tract pressure gradient under resting conditions in HOCM patients, using cardiac ultrasound at a 6-month follow-up. It aims to evaluate the impact of non-invasive SBRT treatment on cardiac function during periods of rest.
Measured: 6 months post-treatment
Impact on NYHA Functional Classification
This outcome evaluates the effect of SBRT on the NYHA functional classification of patients, indicating changes in symptomatic heart failure and overall cardiac performance post-treatment.
Measured: 6 months post-treatment
Changes in Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores
This measure evaluates the effect of treatment on patient quality of life and symptomatic relief. It is quantified using the Kansas City Cardiomyopathy Questionnaire (KCCQ), a comprehensive scale that measures heart failure symptoms and their influence on daily activities. The KCCQ scale ranges from 0 to 100, where higher scores indicate better health status and lower scores signify worse outcomes. This scale effectively captures the patient's experience and the impact of heart failure on their quality of life.
Measured: 6 months post-treatment
Performance in the 6-Minute Walk Test
This outcome evaluates the physical capacity of patients post-treatment, measured through the 6-minute walk test, a standard test of aerobic capacity and endurance.
Measured: 6 months post-treatment
Concentration Changes of NT-proBNP and cTNT Post-SBRT Treatment
This measure monitors the levels of NT-proBNP and cTNT, biomarkers of cardiac stress and damage, post-SBRT treatment, providing insights into the physiological changes within the heart.
Measured: 6 months post-treatment
Impact on QRS Duration
This outcome analyzes the effect of SBRT on QRS duration, assessed through electrocardiogram (ECG), to understand any changes in cardiac electrical activity post-treatment.
Measured: 6 months post-treatment
Incidence of Major Adverse Cardiac Events (MACEs)
This measure tracks the occurrence of major adverse cardiac events within 6 months post-treatment, offering crucial data on the safety profile of SBRT in treating HOCM.
Measured: 6 months post-treatment
Monitoring of Serious Adverse Events (SAEs)
This measure involves meticulous monitoring of any serious adverse events during and after treatment, ensuring a comprehensive safety assessment of SBRT as a therapeutic approach.
Measured: Up to 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start15 Dec 2023
- Primary completion15 Dec 2024 (estimated)
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic Obstructive CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shenghua Zhou, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167876
- Sponsor's protocol ID
- LYG20230056
- Acronym
- SAFECARE
- Status last verified
- Dec 2023
- First submitted
- 3 Dec 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Stereotactic Body Radiotherapy in the Treatment of Hypertrophic Obstructive Cardiomyopathy: A Multicenter, Randomized, Single-blind, Controlled Study
- ClinicalTrials.gov ID
- NCT06167876
- Acronym / sponsor ID
- SAFECARE / LYG20230056
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Body Radiotherapy (SBRT) Treatment Group | Experimental | Radiation: Stereotactic Body Radiotherapy (SBRT) TreatmentThis 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. |
| Sham Procedure Control Group | Sham comparator | Other: Sham ProcedureParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Body Radiotherapy (SBRT) TreatmentThe 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. | Radiation | Stereotactic Body Radiotherapy (SBRT) Treatment Group |
| Sham ProcedureThe 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. | Other | Sham Procedure Control Group |
Primary outcome
Change in Left Ventricular Outflow Tract Pressure Gradient under Provoked Conditions
Time frame: 6 months post-treatment
This primary outcome measure evaluates the effectiveness of non-invasive radiotherapy (SBRT) in altering the left ventricular outflow tract pressure gradient under provoked conditions in patients with Hypertrophic Obstructive Cardiomyopathy (HOCM). The measurement is determined using cardiac ultrasound, assessing the extent to which SBRT can alleviate the obstruction in the heart's outflow tract, a key indicator of therapeutic success in HOCM treatment.
8 secondary outcomes
Change in Left Ventricular Outflow Tract Pressure Gradient under Resting Conditions
Time frame: 6 months post-treatment
Impact on NYHA Functional Classification
Time frame: 6 months post-treatment
Changes in Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores
Time frame: 6 months post-treatment
Performance in the 6-Minute Walk Test
Time frame: 6 months post-treatment
Concentration Changes of NT-proBNP and cTNT Post-SBRT Treatment
Time frame: 6 months post-treatment
Impact on QRS Duration
Time frame: 6 months post-treatment
Incidence of Major Adverse Cardiac Events (MACEs)
Time frame: 6 months post-treatment
Monitoring of Serious Adverse Events (SAEs)
Time frame: Up to 6 months post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Body Radiotherapy (SBRT) Treatment in people with Hypertrophic Obstructive Cardiomyopathy and Stereotactic Body Radiotherapy, run by Second Xiangya Hospital of Central South University at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shenghua Zhou, M.D. (+86 15802609148, zhoushenghua@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Left Ventricular Outflow Tract Pressure Gradient under Provoked Conditions (time frame: 6 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.