Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1000 participants
OBSERVATIONAL
2014-01-31
2023-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Dofetilide patients
Patients admitted for dofetilide initiation
Dofetilide and/or sotalol
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.
Sotalol patients
Patients admitted for sotalol initiation
Dofetilide and/or sotalol
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.
Interventions
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Dofetilide and/or sotalol
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Inability to provide blood samples for DNA testing (anemia, coagulopathy)
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
The Cleveland Clinic
OTHER
University of Colorado, Denver
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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Christopher Newton-Cheh, MD
Overall Principal Investigator
Principal Investigators
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Christopher Newton-Cheh, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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University of Colorado Hospital
Aurora, Colorado, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Cleveland Clinic
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2013P001851
Identifier Type: -
Identifier Source: org_study_id
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