Long QT SyndromeNCT03544918
Prevalence of Congenital Long QT Syndrome and Acquired QT Prolongation in a Hospital Cohort
An observational study of Long QT Syndrome, run by Sykehuset Telemark at 1 site in Norway.
Trial summary
The Long QT syndrome is associated with potentially life-threatening cardiac arrhythmias as ventricular tachycardia (Torsade de pointes) as well as ventricular fibrillation, and might lead to syncope as well as sudden cardiac death (1). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Long QT Syndrome
- How many people
- 1,536 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2015to 6 Nov 2020
- How long will I take part?
- 10 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The Long QT syndrome is associated with potentially life-threatening cardiac arrhythmias. In this study we are using the hospital ECG database obtained with the GE Marquette 12SL ECG Analysis Program® This database stores approximately 200 000 ECG recordings from 60 000 unique patients. By using the search algorithm in the MUSE ECG database, 2398 recordings have been be identified from 1603 patients where the corrected QT time is longer than 500 ms, and QRS is less than 120 ms.
Who may be able to join
- QT time in EKG more Tham 500 ms -
Who cannot join
- Patient refuses to be a part of the study registry
Trial locations and contacts
1 site in 1 country.
About this study
The Long QT syndrome is associated with potentially life-threatening cardiac arrhythmias as ventricular tachycardia (Torsade de pointes) as well as ventricular fibrillation, and might lead to syncope as well as sudden cardiac death (1). Good results have been achieved by treating patient at risk with beta blockers and implantable cardiac defibrillator (ICD). It is therefore important to diagnose the condition as early as possible as the disease is treatable (2).
Prolonged QT duration might also be induced by the intake of numerous pharmaceutical substances, as well as with electrolyte disturbances, which also increases the risk of life-threatening cardiac arrhythmias. Furthermore, congenital LQTS can arise from mutations in one of at least 13 different genes. Many of these genes encode proteins which are constituents of ion channels. The genetically defined long QT syndrome has autosomal dominant (Romano Ward Syndrome) or autosomal recessive (Jervell and Lange-Nielsen Syndrome) inheritance.
Read more
In this study we are using the hospital ECG database obtained with the GE Marquette 12SL ECG Analysis Program® at Telemark Hospital Skien recorded between March 2004 and April 2014. This database stores approximately 200 000 ECG recordings from 60 000 unique patients.
By using the search algorithm in the MUSE ECG database, 2398 recordings have been be identified from 1603 patients where the corrected QT time is longer than 500 ms, and QRS is less than 120 ms.
ECG recordings with QT intervals longer than 500 ms represents less than 1% of the population (5). Individuals having these recordings are selected for extensive clinical follow up. The patients will be offered the opportunity to have genetic analysis performed in order to distinguish between inherited or acquired long QT syndrome. The appropriate treatment will be initiated according to guidelines for patients with inherited QT syndrome. For patients with aquired long QT syndrome substitution of unfavourable pharmacotherapy or correction of electrolytes shall be performed in order to reduce their risk of cardiac arrhythmias.
A T wave morphology score gives independent prognostic information useful for risk stratification. The purpose of this substudy is to examine if the T wave morphology score applied on the 1531 patients ECGs with QTc >500 ms, has independent prognostic value in this cohort.
Read the detailed description
- PURPOSE OF THE STUDY
The study has the intention to:
- Identify patients with inherited LQTS in order to give them optimal treatment.
- To identify patients with acquired QT prolongation in order to possibly correct electrolyte disorders and therapeutically prescriptions in order to minimize the chance of life-threatening arrhythmias.
- To analyse to what extend a specific reason for QT prolongation can be found in patients with heart rate adjusted QT prolongation, or to which extend the QT prolongation without syncope, or family history of sudden cardiac death, is an unspecific finding.
- To analyse time dependent risk of patients with QT prolongation related to underlying disease
- To analyse to what extend genetic variations might predispose for acquired QT prolongation.
- To compare life expectancy of patients with QT prolongation related to case control patients with out QT prolongation.
- To implement rapid reaction on newly diagnosed QT prolongation, and follow up of survival after implementation of improved care.
- To examine if the T wave morphology score applied on patients ECGs with QTc >500 ms, has independent prognostic value in this cohort.
- Conditions
- Long QT Syndrome
- Medical subject headings
- Long QT Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with long QT syndrome. | Patents with Long QT syndrome hospitilized. To be followed over time with no intervention. Observational study. | |
| Patients in Telemark with normal QT time | Patients in Telemark with normal QT time. To be followed over time with no intervention. Observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival
Death certificate information from national register
Measured: 2004-2014
Secondary outcomes (1)
comorbidity data from hospital database Genetic defects data
Data extracted from hospital notes
Measured: 2004-2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study startJun 2015
- Primary completion6 Nov 2020
- Study completion6 Nov 2020
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
- Cross-sectional
- Enrolment
- 1,536 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Sykehuset Telemark
- Sponsor type
- Other government
- Collaborators
- Oslo University Hospital
- Responsible party
- Principal investigator, Jan Hysing MD PhD, Sykehuset Telemark
- Investigators
- Jan Hysing, PhD, Principal investigator, Sykehuset Telemark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544918
- Sponsor's protocol ID
- REK 2013/1090
- Status last verified
- Nov 2020
- First submitted
- 22 May 2018
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Congenital Long QT Syndrome and Acquired QT Prolongation in a Hospital Cohort
- ClinicalTrials.gov ID
- NCT03544918
- Acronym / sponsor ID
- REK 2013/1090
- Conditions
- Long QT Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,536 participants (actual)
- Lead sponsor
- Sykehuset TelemarkOther government
- Collaborators
- Oslo University Hospital
- Study start
- Jun 2015
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 6 Nov 2020 (actual)
- First posted
- 4 Jun 2018 (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 Long QT syndrome is associated with potentially life-threatening cardiac arrhythmias as ventricular tachycardia (Torsade de pointes) as well as ventricular fibrillation, and might lead to syncope as well as sudden cardiac death (1). Good results have been achieved by treating patient at risk with beta blockers and implantable cardiac defibrillator (ICD). It is therefore important to diagnose the condition as early as possible as the disease is treatable (2).
Prolonged QT duration might also be induced by the intake of numerous pharmaceutical substances, as well as with electrolyte disturbances, which also increases the risk of life-threatening cardiac arrhythmias. Furthermore, congenital LQTS can arise from mutations in one of at least 13 different genes. Many of these genes encode proteins which are constituents of ion channels. The genetically defined long QT syndrome has autosomal dominant (Romano Ward Syndrome) or autosomal recessive (Jervell and Lange-Nielsen Syndrome) inheritance.
In this study we are using the hospital ECG database obtained with the GE Marquette 12SL ECG Analysis Program® at Telemark Hospital Skien recorded between March 2004 and April 2014. This database stores approximately 200 000 ECG recordings from 60 000 unique patients.
By using the search algorithm in the MUSE ECG database, 2398 recordings have been be identified from 1603 patients where the corrected QT time is longer than 500 ms, and QRS is less than 120 ms.
ECG recordings with QT intervals longer than 500 ms represents less than 1% of the population (5). Individuals having these recordings are selected for extensive clinical follow up. The patients will be offered the opportunity to have genetic analysis performed in order to distinguish between inherited or acquired long QT syndrome. The appropriate treatment will be initiated according to guidelines for patients with inherited QT syndrome. For patients with aquired long QT syndrome substitution of unfavourable pharmacotherapy or correction of electrolytes shall be performed in order to reduce their risk of cardiac arrhythmias.
A T wave morphology score gives independent prognostic information useful for risk stratification. The purpose of this substudy is to examine if the T wave morphology score applied on the 1531 patients ECGs with QTc >500 ms, has independent prognostic value in this cohort.
Detailed description
- PURPOSE OF THE STUDY
The study has the intention to:
- Identify patients with inherited LQTS in order to give them optimal treatment.
- To identify patients with acquired QT prolongation in order to possibly correct electrolyte disorders and therapeutically prescriptions in order to minimize the chance of life-threatening arrhythmias.
- To analyse to what extend a specific reason for QT prolongation can be found in patients with heart rate adjusted QT prolongation, or to which extend the QT prolongation without syncope, or family history of sudden cardiac death, is an unspecific finding.
- To analyse time dependent risk of patients with QT prolongation related to underlying disease
- To analyse to what extend genetic variations might predispose for acquired QT prolongation.
- To compare life expectancy of patients with QT prolongation related to case control patients with out QT prolongation.
- To implement rapid reaction on newly diagnosed QT prolongation, and follow up of survival after implementation of improved care.
- To examine if the T wave morphology score applied on patients ECGs with QTc >500 ms, has independent prognostic value in this cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with long QT syndrome. | – | –Patents with Long QT syndrome hospitilized. To be followed over time with no intervention. Observational study. |
| Patients in Telemark with normal QT time | – | –Patients in Telemark with normal QT time. To be followed over time with no intervention. Observational study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The Long QT syndrome is associated with potentially life-threatening cardiac arrhythmias. In this study we are using the hospital ECG database obtained with the GE Marquette 12SL ECG Analysis Program® This database stores approximately 200 000 ECG recordings from 60 000 unique patients. By using the search algorithm in the MUSE ECG database, 2398 recordings have been be identified from 1603 patients where the corrected QT time is longer than 500 ms, and QRS is less than 120 ms.
Key inclusion criteria (1 listed)
- QT time in EKG more Tham 500 ms -
Key exclusion criteria (1 listed)
- Patient refuses to be a part of the study registry
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
survival
Time frame: 2004-2014
Death certificate information from national register
1 secondary outcome
comorbidity data from hospital database Genetic defects data
Time frame: 2004-2014
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 9 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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.
Jan Hysing, PhD principal investigator
Sykehuset Telemark
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 Sykehuset Telemark at 1 site in Norway.
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 1 inclusion and 1 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 9 Nov 2020. 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 Norway. 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?
survival (time frame: 2004-2014). 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 9 Nov 2020.