Long QT SyndromeNCT00221832
Molecular Genetic Screening and Identification of Congenital Arrhythmogenic Diseases
An observational study of Long QT Syndrome and Hypertrophic Cardiomyopathy, run by Heidelberg University at 1 site in Germany.
Trial summary
The aim of this study is the identification of familial congenital arrhythmogenic disorders and their clinical follow-up. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Long QT Syndrome, Hypertrophic Cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2003to Dec 2011
- 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: Consecutive patient sampling with history of syncope, aborted SCD, familial sudden cardiac death, high suspicion of familial cardiac arrhythmias.
Who may be able to join
- Patients with a history of syncope, abnormal ECG and suspicion of an arrhythmogenic disease
- Patients with long QT syndrome
- Patients with short QT syndrome, shortened QT intervals, borderline shortened QT intervals
- Patients with Brugada syndrome
- Patients with hypertrophic cardiomyopathy
- Patients with arrhythmogenic right ventricular dysplasia
Who cannot join
- Inability to understand study protocol
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Mannheim, I. Department of Medicine
Mannheim, 68167
Christian Wolpert, MD, +49-621-3832206, christian.wolpert@med.ma.uni-heidelberg.de
Rainer Schimpf, MD, +49-621-3832206, rainer.schimpf@med.ma.uni-heidelberg.de
About this study
The aim of this study is the identification of familial congenital arrhythmogenic disorders and their clinical follow-up.
Read the detailed description
Molecular genetic screening in patients with:
- supraventricular
- ventricular arrhythmia
- syncopes of unknown origin and/or suspicion of an arrhythmogenic origin
- family members of patients with sudden cardiac death and aborted sudden cardiac death
Examination of patients includes routine testing like electrocardiogram (ECG), sequential ECGs, exercise testing, invasive electrophysiological stimulation, cardiac magnetic resonance imaging, intravenous drug challenge for identification/exclusion of eg Brugada syndrome. Examples are patients with Long QT Syndrome, Short QT Syndrome, Brugada Syndrome, familial atrial fibrillation, WPW-syndrome, arrhythmias due to familial hypertrophic cardiomyopathy or arrhythmogenic right ventricular dysplasia. Blood samples are taken for further molecular genetic screening.
- Keywords
- Long QT Syndrome, Hypertrophic cardiomyopathy, arrhythmogenic right ventricular dysplasia, Short QT Syndrome, Brugada Syndrome
- Medical subject headings
- Long QT Syndrome, Cardiomyopathy, Hypertrophic, Arrhythmogenic Right Ventricular Dysplasia, Short Qt Syndrome, Brugada Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startOct 2003
- Study completionDec 2011 (estimated)
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
- Family based
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Investigators
- Martin Borggrefe, Prof., MD, Study director, I. Department of Medicine-Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221832
- Sponsor's protocol ID
- 0261.5
- Status last verified
- Oct 2003
- First submitted
- 14 Sep 2005
- Last updated
- 13 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Genetic Screening and Identification of Congenital Arrhythmogenic Diseases
- ClinicalTrials.gov ID
- NCT00221832
- Acronym / sponsor ID
- 0261.5
- Keywords
- Long QT Syndrome, Hypertrophic cardiomyopathy, arrhythmogenic right ventricular dysplasia, Short QT Syndrome, Brugada Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Oct 2003
- Study completion
- Dec 2011 (estimated)
- First posted
- 22 Sep 2005 (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 aim of this study is the identification of familial congenital arrhythmogenic disorders and their clinical follow-up.
Detailed description
Molecular genetic screening in patients with:
- supraventricular
- ventricular arrhythmia
- syncopes of unknown origin and/or suspicion of an arrhythmogenic origin
- family members of patients with sudden cardiac death and aborted sudden cardiac death
Examination of patients includes routine testing like electrocardiogram (ECG), sequential ECGs, exercise testing, invasive electrophysiological stimulation, cardiac magnetic resonance imaging, intravenous drug challenge for identification/exclusion of eg Brugada syndrome. Examples are patients with Long QT Syndrome, Short QT Syndrome, Brugada Syndrome, familial atrial fibrillation, WPW-syndrome, arrhythmias due to familial hypertrophic cardiomyopathy or arrhythmogenic right ventricular dysplasia. Blood samples are taken for further molecular genetic screening.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patient sampling with history of syncope, aborted SCD, familial sudden cardiac death, high suspicion of familial cardiac arrhythmias.
Key inclusion criteria (6 listed)
- Patients with a history of syncope, abnormal ECG and suspicion of an arrhythmogenic disease
- Patients with long QT syndrome
- Patients with short QT syndrome, shortened QT intervals, borderline shortened QT intervals
- Patients with Brugada syndrome
- Patients with hypertrophic cardiomyopathy
Key exclusion criteria (1 listed)
- Inability to understand study protocol
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2010.
Related trials for Long QT Syndrome
Active, not recruitingPhase 1/2
Opt-IVF for Personalized Medicine for Normal Responders
Ivf
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
Active, not recruitingObservational study
Observational Study to Describe Health-Related Quality of Life and Measure Disease Burden Among Patients With Long QT Syndrome Types (LQTS) 2 and 3
Long QT Syndrome Type 3, Long QT Syndrome 2
Not yet recruitingObservational study
Physical Activity and Functional Capacity in Patients With Congenital Long QT Syndrome
Long QT Syndrome, Channelopathies
Recruiting
Dual Trigger VS HCG Trigger for Final Oocyte Maturation in Normal Responders
ICSI, IVF
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.
Martin Borggrefe, Prof., MD study director
I. Department of Medicine-Cardiology
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 and Hypertrophic Cardiomyopathy, run by Heidelberg University at 1 site in Germany.
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 6 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: status not confirmed, as of the sponsor's last update on 13 Jan 2010. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Wolpert, MD (+49-621-383-2206, christian.wolpert@med.ma.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 13 Jan 2010.