Hypertrophic Obstructive CardiomyopathySELECTNCT04686487
SterEotactic AbLative Radiotherapy in PatiEnts With HypertrophiC ObstrucTive Cardiomyopathy
A study testing stereotactic ablative radiotherapy in people with Hypertrophic Obstructive Cardiomyopathy, run by Second Xiangya Hospital of Central South University at 1 site in China.
Trial summary
Hypertrophic obstructive cardiomyopathy (HOCM) is an inherited myocardial disease which leads to the muscle in the wall of the heart growing and thickening to the point that it blocks blood flow exiting the heart with increasing risk of sudden cardiac death, heart failure, and atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Obstructive Cardiomyopathy
- What is being tested?
- stereotactic ablative radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2021to 1 Nov 2022
- 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
- Male or female aged ≥ 18 years
- Drug-refractory symptomatic patients with HOCM
- Willing and able to give written informed consent
Who cannot join
- Enrolled in another clinical study.
- Patient unable to tolerate lying flat for one hour
- Pregnant Or Lactating Women
- With other contraindications for receive stereotactic ablative radiotherapy
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
About this study
Official title: Stereotactic Ablative Radiotherapy in Patients With Hypertrophic Obstructive Cardiomyopathy: First in Man Pilot Study
Hypertrophic obstructive cardiomyopathy (HOCM) is an inherited myocardial disease which leads to the muscle in the wall of the heart growing and thickening to the point that it blocks blood flow exiting the heart with increasing risk of sudden cardiac death, heart failure, and atrial fibrillation. Surgical septal myectomy and alcohol septal ablation are two invasive therapies for drug-refractory symptomatic patients with HOCM. Unfortunately, some patients may be unsuitable for both the two procedures. Recently, stereotactic ablative radiotherapy, usually used for the treatment of tumours, was confirmed to be feasible, safe and effective in destroying abnormal tissue in heart by targeting high energy heavy ion beams at a specific area of the body precisely. In this study we will determine whether radiation ablation, can be used to destroy the thick heart muscle at the point of obstruction safely and effectively.
- Conditions
- Hypertrophic Obstructive Cardiomyopathy
- Being tested
- stereotactic ablative radiotherapy
- Keywords
- Hypertrophic Obstructive Cardiomyopathy, Stereotactic Ablative Radiotherapy
- 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 ablative radiotherapyProcedure or surgery
stereotactic ablative radiotherapy by targeting high energy heavy ion beams at a specific area of the body
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Ablative Radiotherapy | Other | Stereotactic body radiation therapy delivered to the thick heart muscle at the point of obstruction Receives: Procedure: stereotactic ablative radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of stereotactic ablative radiotherapy
The primary safety endpoint is defined as serious adverse events (SAEs) that are possibly/probably/definitely related to study treatment, based on previously published data for expected invasive alcohol septal-ablation procedures.
Measured: 3 months
Secondary outcomes (5)
Assessment of MACE endpoints
death, heart failure, myocardial infarction and stroke
Measured: 1, 3, 6 and 12 months
Development of complete heart block, atrial or ventricular arrhythmias
diagnosis by electrocardiogram
Measured: 1, 3, 6 and 12 months
Change in LVOT gradient
Assessed with transthoracic echocardiography
Measured: 1, 3, 6 and 12 months
Change in exercise capacity
6 minute Walk Test
Measured: 1, 3, 6 and 12 months
Change in LV wall thickness
Measured on echocardiography
Measured: 1, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start12 Jan 2021
- Primary completion30 Apr 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
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
- NCT04686487
- Sponsor's protocol ID
- HOCM2018044
- Acronym
- SELECT
- Status last verified
- Nov 2022
- First submitted
- 15 Dec 2020
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li X, Zhu Z, Liu J, Gao Y, Xiao Y, Fang Z, Liu Q, Liu X, Hu C, Ma F, Zeng M, Liu Z, Hu L, Liu N, Xiang F, Hu X, Huang L, Zhou S. Septal radioablation therapy for patients with hypertrophic obstructive cardiomyopathy: first-in-human study. Eur Heart J Open. 2023 May 23;3(3):oead052. doi: 10.1093/ehjopen/oead052. eCollection 2023 May.
PubMed 37503357
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Ablative Radiotherapy in Patients With Hypertrophic Obstructive Cardiomyopathy: First in Man Pilot Study
- ClinicalTrials.gov ID
- NCT04686487
- Acronym / sponsor ID
- SELECT / HOCM2018044
- Conditions
- Hypertrophic Obstructive Cardiomyopathy
- Keywords
- Hypertrophic Obstructive Cardiomyopathy, Stereotactic Ablative Radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 28 Dec 2020 (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.
Hypertrophic obstructive cardiomyopathy (HOCM) is an inherited myocardial disease which leads to the muscle in the wall of the heart growing and thickening to the point that it blocks blood flow exiting the heart with increasing risk of sudden cardiac death, heart failure, and atrial fibrillation. Surgical septal myectomy and alcohol septal ablation are two invasive therapies for drug-refractory symptomatic patients with HOCM. Unfortunately, some patients may be unsuitable for both the two procedures. Recently, stereotactic ablative radiotherapy, usually used for the treatment of tumours, was confirmed to be feasible, safe and effective in destroying abnormal tissue in heart by targeting high energy heavy ion beams at a specific area of the body precisely. In this study we will determine whether radiation ablation, can be used to destroy the thick heart muscle at the point of obstruction safely and effectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Ablative Radiotherapy | Other | Procedure: stereotactic ablative radiotherapyStereotactic body radiation therapy delivered to the thick heart muscle at the point of obstruction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female aged ≥ 18 years
- Drug-refractory symptomatic patients with HOCM
- Willing and able to give written informed consent
Key exclusion criteria (4 listed)
- Enrolled in another clinical study.
- Patient unable to tolerate lying flat for one hour
- Pregnant Or Lactating Women
- With other contraindications for receive stereotactic ablative radiotherapy
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 ablative radiotherapystereotactic ablative radiotherapy by targeting high energy heavy ion beams at a specific area of the body | Procedure or surgery | Stereotactic Ablative Radiotherapy |
Primary outcome
Safety of stereotactic ablative radiotherapy
Time frame: 3 months
The primary safety endpoint is defined as serious adverse events (SAEs) that are possibly/probably/definitely related to study treatment, based on previously published data for expected invasive alcohol septal-ablation procedures.
5 secondary outcomes
Assessment of MACE endpoints
Time frame: 1, 3, 6 and 12 months
Development of complete heart block, atrial or ventricular arrhythmias
Time frame: 1, 3, 6 and 12 months
Change in LVOT gradient
Time frame: 1, 3, 6 and 12 months
Change in exercise capacity
Time frame: 1, 3, 6 and 12 months
Change in LV wall thickness
Time frame: 1, 3, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Derived from this study: PubMed 37503357Li X, Zhu Z, Liu J, Gao Y, Xiao Y, Fang Z, Liu Q, Liu X, Hu C, Ma F, Zeng M, Liu Z, Hu L, Liu N, Xiang F, Hu X, Huang L, Zhou S. Septal radioablation therapy for patients with hypertrophic obstructive cardiomyopathy: first-in-human study. Eur Heart J Open. 2023 May 23;3(3):oead052. doi: 10.1093/ehjopen/oead052. eCollection 2023 May.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stereotactic ablative radiotherapy in people with Hypertrophic Obstructive Cardiomyopathy, run by Second Xiangya Hospital of Central South University at 1 site 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of stereotactic ablative radiotherapy (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04686487, which also lists 1 linked publication.
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 30 Nov 2022.