Long QT SyndromeNCT01705925
Multicenter Evaluation of Children and Young Adults With Genotype Positive Long QT Syndrome
An observational study of Long QT Syndrome, run by Pediatrix at 1 site in United States.
Trial summary
The purpose of the study is to provide comprehensive follow-up in patients with Long QT Syndrome (LQTS) and gain additional information regarding genotype-phenotype correlation and effective management and treatment options. Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Long QT Syndrome
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Dec 2018
- 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 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and Young Adults with Genotype Positive Long QT Syndrome
Who may be able to join
- Children and/or young adults diagnosed with heterogeneous repolarization disorder who have genotype positive Long QT, or
- Newly diagnosed mutation positive patients with a confirmed test
Who cannot join
- Children who are phenotypically positive with no molecular testing
- Children that are phenotypically positive but genotype negative
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Cardiology Associates
Austin, Texas, 78756
About this study
The purpose of the study is to provide comprehensive follow-up in patients with Long QT Syndrome (LQTS) and gain additional information regarding genotype-phenotype correlation and effective management and treatment options.
- Conditions
- Long QT Syndrome
- Medical subject headings
- Long QT Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Cardiac Events on patients with genotype positive LQT1 who have a normal EKG and absence of symptoms, but a molecular confirmation of LQT1.
Measured: Enrollment is expected to take approximately 5 years. The patients will be followed until they are no longer cared for by a pediatric cardiology facility (typically post-college) or approximately 21 years of age.
Secondary outcomes (1)
Adverse Cardiac Events on patients with both phenotype and genotype positive.
Measured: Enrollment is expected to take approximately 5 years. The patients will be followed until they are no longer cared for by a pediatric cardiology facility (typically post-college) or approximately 21 years of age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long QT SyndromeStudies 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
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pediatrix
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mitchell Cohen, M.D., Principal investigator, PediatrixArnold Fenrich, MD, Principal investigator, PediatrixReese Clark, MD, Study director, Pediatrix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01705925
- Sponsor's protocol ID
- PDX-002-11
- Status last verified
- May 2019
- First submitted
- 4 Oct 2012
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Evaluation of Children and Young Adults With Genotype Positive Long QT Syndrome
- ClinicalTrials.gov ID
- NCT01705925
- Acronym / sponsor ID
- PDX-002-11
- Conditions
- Long QT Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- PediatrixUniversity, hospital or other
- Study start
- Mar 2012 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 12 Oct 2012 (estimated)
- 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 purpose of the study is to provide comprehensive follow-up in patients with Long QT Syndrome (LQTS) and gain additional information regarding genotype-phenotype correlation and effective management and treatment options.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and Young Adults with Genotype Positive Long QT Syndrome
Key inclusion criteria (2 listed)
- Children and/or young adults diagnosed with heterogeneous repolarization disorder who have genotype positive Long QT, or
- Newly diagnosed mutation positive patients with a confirmed test
Key exclusion criteria (2 listed)
- Children who are phenotypically positive with no molecular testing
- Children that are phenotypically positive but genotype negative
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
Adverse Cardiac Events on patients with genotype positive LQT1 who have a normal EKG and absence of symptoms, but a molecular confirmation of LQT1.
Time frame: Enrollment is expected to take approximately 5 years. The patients will be followed until they are no longer cared for by a pediatric cardiology facility (typically post-college) or approximately 21 years of age.
1 secondary outcome
Adverse Cardiac Events on patients with both phenotype and genotype positive.
Time frame: Enrollment is expected to take approximately 5 years. The patients will be followed until they are no longer cared for by a pediatric cardiology facility (typically post-college) or approximately 21 years of age.
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 6 May 2019.
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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.
Mitchell Cohen, M.D. principal investigator
Pediatrix
Arnold Fenrich, MD principal investigator
Pediatrix
Reese Clark, MD study director
Pediatrix
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long QT Syndrome, run by Pediatrix at 1 site in United States.
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 2 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 6 May 2019. 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 United States. 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?
Adverse Cardiac Events on patients with genotype positive LQT1 who have a normal EKG and absence of symptoms, but a molecular confirmation of LQT1. (time frame: Enrollment is expected to take approximately 5 years. The patients will be followed until they are no longer cared for by a pediatric cardiology facility (typically post-college) or approximately 21 years of age.). 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 6 May 2019.