- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02439658
Genetics of QT Prolongation With Antiarrhythmics (DOFEGEN)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a multi-center study attempting to identify genetic and other factors that influence QT interval response to dofetilide or sotalol. One of the goals of this study is to determine whether genetics might identify individuals at low enough genetic risk for QT prolongation that outpatient initiation might be feasible. The dofetilide or sotalol use will be solely determined by clinical staff independent of the research study based on standard clinical care. The research components of this study include only the additional collection of blood for genetic analysis, collection of subject data on a CRF and copies of electrocardiograms performed as part of routine clinical care. This study will be overseen and coordinated at MGH. Other hospitals that may participate include Mayo Clinic, Cleveland Clinic, and University of Colorado Hospital; local IRB approval will be sought at each of these centers. Data will be collected at each individual hospital by co-investigators/site PIs and stored locally according to IRB requirements. Copies of CRFs, ECGs and blood samples for genetic analysis will be forwarded to MGH, which will serve as a coordinating and analysis center (as well as a recruiting center). Data will be encoded where possible; however, due to the impracticality of removing patient identifiers from certain data types, such as medication lists and ECGs, some data containing patient information will be transported and stored at MGH. Dr. Newton-Cheh will serve as overall study PI.
The investigators propose to conduct a research study to examine known and explore potentially unknown genetic predictors of QT response in patients being admitted for dofetilide or sotalol initiation as part of their routine clinical care. Any patient being admitted to a participating institution for the purpose of dofetilide or sotalol initiation will be eligible. Patients must be able to understand the risks of genetic testing, and be willing to undergo a venipuncture for blood collection for genotyping. Exclusion criteria include inability to provide informed consent. The investigators have a goal to enroll a total of 1000 study participants across all collaborating centers.
Patients will be identified by investigators based on planned admission for dofetilide or sotalol initiation, and following explanation of the study by co-investigator, will be asked about study participation and informed consent will be obtained. Investigators will complete a data collection form for each patient, which will include contact information, demographic information, clinical information, family history and pedigree, and all electrocardiography information available (tracings, reports). Patients will then undergo venipuncture, and two 5mL blood samples (tubes) will be collected for genotyping. Patients will also be consented for future re-contact about additional data, information, or samples needed for analysis.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Christopher Newton-Cheh, MD, MPH
- Phone Number: 617-724-6158
- Email: cnewtoncheh@mgh.harvard.edu
Study Contact Backup
- Name: Elizabeth Farland, BS
- Phone Number: 617-643-6328
- Email: efarland@mgh.harvard.edu
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Recruiting
- University of Colorado Hospital
-
Contact:
- Michael Rosenberg, MD
- Email: MICHAEL.A.ROSENBERG@UCDENVER.EDU
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Recruiting
- Massachusetts General Hospital
-
Contact:
- Christopher Newton-Cheh, MD, MPH
- Phone Number: 617-643-7995
- Email: cnewtoncheh@mgh.harvard.edu
-
Boston, Massachusetts, United States, 02215
- Completed
- Beth Israel Deaconess Medical Center
-
-
Minnesota
-
Rochester, Minnesota, United States, 55902
- Recruiting
- Mayo Clinic
-
Contact:
- Peter Nosewothy, MD
- Email: Noseworthy.Peter@mayo.edu
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Recruiting
- Cleveland Clinic
-
Contact:
- Khaldoun Tarakji, MD,MPH
- Email: TARAKJK@ccf.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients admitted for dovetailed or sotalol initiation for clinical purposes.
Exclusion Criteria:
- Inability to provide informed consent
- Inability to provide blood samples for DNA testing (anemia, coagulopathy)
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Dofetilide patients
Patients admitted for dofetilide initiation
|
This is an observational study of patients receiving Dofetilide and/or sotalol as part of their routine clinical care.
Patients receiving either of these medications will be compared with population controls for genetic analysis.
Other Names:
|
Sotalol patients
Patients admitted for sotalol initiation
|
This is an observational study of patients receiving Dofetilide and/or sotalol as part of their routine clinical care.
Patients receiving either of these medications will be compared with population controls for genetic analysis.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
QT interval
Time Frame: QT intervals will be measured on each ECG obtained during the index hospitalization
|
QT interval will be measured on electrocardiograms, and recorded in the case report form
|
QT intervals will be measured on each ECG obtained during the index hospitalization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Successful drug initiation
Time Frame: Patient will be followed for the duration of the hospitalization, which is on average 3 days
|
This outcome will be recorded in the case report form
|
Patient will be followed for the duration of the hospitalization, which is on average 3 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christopher Newton-Cheh, MD, MPH, Massachusetts General Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Congenital Abnormalities
- Arrhythmias, Cardiac
- Cardiac Conduction System Disease
- Heart Defects, Congenital
- Cardiovascular Abnormalities
- Drug-Related Side Effects and Adverse Reactions
- Long QT Syndrome
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Membrane Transport Modulators
- Sympatholytics
- Potassium Channel Blockers
- Sotalol
- Dofetilide
Other Study ID Numbers
- 2013P001851
- 5R01HL143070 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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