Recruiting

Genetics of QT

Sponsor:

Massachusetts General Hospital

Code:

NCT02439658

Conditions

Long QT Syndrome

Drug Toxicity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dofetilide and/or sotalol

Study Details

Brief summary:

To assess the ability of common genetic variants in aggregate to predict drug-induced QT prolongation in patients being loaded with dofetilide or sotalol.

Conditions

Long QT Syndrome

Drug Toxicity

Study ID

NCT02439658

Start date

Jan, 2014

Status verified date

Mar, 2022

Completion date

Apr 30, 2023

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Dofetilide patients

Patients admitted for dofetilide initiation

Sotalol patients

Patients admitted for sotalol initiation

Interventions

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.

Primary outcome measure

  • QT interval [ Time Frame: QT intervals will be measured on each ECG obtained during the index hospitalization ]

Central Contacts and Locations

Central contacts

Christopher Newton-Cheh, MD, MPH

617-724-6158cnewtoncheh@mgh.harvard.edu

Elizabeth Farland, BS

617-643-6328efarland@mgh.harvard.edu

Locations

University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Michael Rosenberg, MD

MICHAEL.A.ROSENBERG@UCDENVER.EDU

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Christopher Newton-Cheh, MD, MPH

617-643-7995cnewtoncheh@mgh.harvard.edu

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55902

Contacts

Peter Nosewothy, MD

Noseworthy.Peter@mayo.edu

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Khaldoun Tarakji, MD,MPH

TARAKJK@ccf.org

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Apr 4, 2022

Last verified

Mar, 2022

Keywords

  • genetic research

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2022-04-04.