Hypertrophic Obstructive CardiomyopathyNCT05687487
Residual or Recurrent Obstruction After Septal Myectomy
An observational study of Hypertrophic Obstructive Cardiomyopathy, run by Chinese Academy of Medical Sciences, Fuwai Hospital.
Trial summary
The goal of this observational study is to report the outcomes after septal myectomy in young children and infants and identify the mechanisms of residual or recurrent obstruction after surgery. Read more about this study
- Who is it for?
- Ages Up to 14 years
- Conditions the study is for
- Hypertrophic Obstructive Cardiomyopathy
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 1 Feb 2021
- How long will I take part?
- 24 Months
- Phase
- Observational
- 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 Up to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with HOCM who remain severely symptomatic despite medical therapy or have a particularly high resting LVOT gradients (>100mmHg) underwent septal myectomy by the same surgeon Y from January 2013 to December 2020. A total of 56 consecutive children younger than 14 were included. All patients were on Beta blockers therapy and symptomatic.
Who may be able to join
- Clinical diagnosis of hypertrophic obstructive cardiomyopathy (HOCM)
- Age young than 14 years
- Patients who have undergone septal myectomy
Who cannot join
- older than 14 years old;
- secondary left ventricular hypertrophy (LVH) related to subaortic stenosis or aortic stenosis.
About this study
Official title: Residual or Recurrent Obstruction After Septal Myectomy in Young Children and Infants With Hypertrophic Cardiomyopathy
The goal of this observational study is to report the outcomes after septal myectomy in young children and infants and identify the mechanisms of residual or recurrent obstruction after surgery. in The main question[s] it aims to answer are:
- What is the early and mid-term results of septal myectomy in young children and infants with severe and extensive obstructive hypertrophic cardiomyopathy (HCM)?
- What are the mechanisms of residual or recurrent obstruction?
Echocardiography and clinical course of children and infants under the age of 14 who underwent septal myectomy for hypertrophic obstructive cardiomyopathy from January 2013 to December 2020 will be followed up.
- Conditions
- Hypertrophic Obstructive Cardiomyopathy
- Keywords
- Septal myectomy, Residual or recurrent obstruction, children and infants, hypertrophic obstructive cardiomyopathy
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Bites and Stings
What is being measured
The primary outcome is the main question the study is designed to answer.
death
postoperative death during follow-up
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
recurrent obstruction
postoperative recurrent obstruction during follow-up
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start1 Jan 2013
- Primary completion31 Dec 2020
- Study completion1 Feb 2021
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Yan, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687487
- Sponsor's protocol ID
- 2020-I2M-C&T-B-060
- Status last verified
- Jan 2023
- First submitted
- 6 Jan 2023
- Last updated
- 18 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dong S, Du C, Song J, Dong J, Meng H, Xu H, Sun Y, Zou M, Li S, Yan J. Residual or recurrent obstruction after septal myectomy in young children and infants with hypertrophic cardiomyopathy: cohort study. Int J Surg. 2023 Jun 1;109(6):1699-1707. doi: 10.1097/JS9.0000000000000426.
PubMed 37165977
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Residual or Recurrent Obstruction After Septal Myectomy in Young Children and Infants With Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT05687487
- Acronym / sponsor ID
- 2020-I2M-C&T-B-060
- Conditions
- Hypertrophic Obstructive Cardiomyopathy
- Keywords
- Septal myectomy, Residual or recurrent obstruction, children and infants, hypertrophic obstructive cardiomyopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 18 Jan 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.
The goal of this observational study is to report the outcomes after septal myectomy in young children and infants and identify the mechanisms of residual or recurrent obstruction after surgery. in The main question[s] it aims to answer are:
- What is the early and mid-term results of septal myectomy in young children and infants with severe and extensive obstructive hypertrophic cardiomyopathy (HCM)?
- What are the mechanisms of residual or recurrent obstruction?
Echocardiography and clinical course of children and infants under the age of 14 who underwent septal myectomy for hypertrophic obstructive cardiomyopathy from January 2013 to December 2020 will be followed up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- Up to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with HOCM who remain severely symptomatic despite medical therapy or have a particularly high resting LVOT gradients (>100mmHg) underwent septal myectomy by the same surgeon Y from January 2013 to December 2020. A total of 56 consecutive children younger than 14 were included. All patients were on Beta blockers therapy and symptomatic.
Key inclusion criteria (3 listed)
- Clinical diagnosis of hypertrophic obstructive cardiomyopathy (HOCM)
- Age young than 14 years
- Patients who have undergone septal myectomy
Key exclusion criteria (2 listed)
- older than 14 years old;
- secondary left ventricular hypertrophy (LVH) related to subaortic stenosis or aortic stenosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
death
Time frame: through study completion, an average of 1 year
postoperative death during follow-up
1 secondary outcome
recurrent obstruction
Time frame: through study completion, an average of 1 year
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 18 Jan 2023.
- Derived from this study: PubMed 37165977Dong S, Du C, Song J, Dong J, Meng H, Xu H, Sun Y, Zou M, Li S, Yan J. Residual or recurrent obstruction after septal myectomy in young children and infants with hypertrophic cardiomyopathy: cohort study. Int J Surg. 2023 Jun 1;109(6):1699-1707. doi: 10.1097/JS9.0000000000000426.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertrophic Obstructive Cardiomyopathy, run by Chinese Academy of Medical Sciences, Fuwai Hospital.
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 2 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 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
death (time frame: through study completion, an average of 1 year). 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 NCT05687487, 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 18 Jan 2023.