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Trial record 1 of 4 for:    newton-cheh
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Genetics of QT Prolongation With Antiarrhythmics (DOFEGEN)

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2016 by Christopher Newton-Cheh, MD, Massachusetts General Hospital
Sponsor:
Collaborators:
VA Office of Research and Development
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Information provided by (Responsible Party):
Christopher Newton-Cheh, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02439658
First received: May 5, 2015
Last updated: March 27, 2016
Last verified: March 2016
  Purpose
To assess the ability of common genetic variants in aggregate to predict drug-induced QT prolongation in patients being loaded with dofetilide or sotalol, and validate the feasibility of using a smartphone device for measuring QT interval.

Condition Intervention
Long QT Syndrome Drug Toxicity Drug: Dofetilide and/or sotalol

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Genetics of QT Prolongation With Antiarrhythmics

Resource links provided by NLM:


Further study details as provided by Christopher Newton-Cheh, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Biospecimen Retention:   Samples With DNA
Blood samples for DNA extraction

Estimated Enrollment: 500
Study Start Date: January 2014
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Dofetilide patients
Patients admitted for dofetilide initiation
Drug: 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 Name: Tikosyn
Sotalol patients
Patients admitted for sotalol initiation
Drug: 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 Name: Tikosyn

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients admitted for dovetailed or sotalol initiation for clinical purposes.
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02439658

Contacts
Contact: Christopher Newton-Cheh, MD, MPH 617-643-7995 cnewtoncheh@mgh.harvard.edu
Contact: Michael A Rosenberg, MD 617-726-3592 marosenberg@mgh.harvard.edu

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Christopher Newton-Cheh, MD, MPH    617-643-7995    cnewtoncheh@mgh.harvard.edu   
Contact: Michael A Rosenberg, MD    617-726-3592    marosenberg@mgh.harvard.edu   
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Saumya Das, MD, PhD    617-667-8800    sdas@bidmc.harvard.edu   
Brigham and Womens Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Christine Albert, MD, MPH    617-732-5500    calbert@mgh.harvard.edu   
Contact: Ciorsti MacIntyre, MD    617-732-5500    cmacintyre@partners.org   
West Roxbury VA Medical Center Recruiting
West Roxbury, Massachusetts, United States, 02132
Contact: Michael A Rosenberg, MD    857-203-6840    michael.rosenberg@va.gov   
Sponsors and Collaborators
Massachusetts General Hospital
VA Office of Research and Development
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Investigators
Principal Investigator: Christopher Newton-Cheh, MD, MPH Massachusetts General Hospital
  More Information

Responsible Party: Christopher Newton-Cheh, MD, Overall Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02439658     History of Changes
Other Study ID Numbers: 2013P001851
Study First Received: May 5, 2015
Last Updated: March 27, 2016

Keywords provided by Christopher Newton-Cheh, MD, Massachusetts General Hospital:
genetic research

Additional relevant MeSH terms:
Long QT Syndrome
Drug-Related Side Effects and Adverse Reactions
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Pathologic Processes
Chemically-Induced Disorders
Dofetilide
Anti-Arrhythmia Agents
Sotalol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Potassium Channel Blockers
Membrane Transport Modulators

ClinicalTrials.gov processed this record on August 18, 2017