Genetics of QT Prolongation With Antiarrhythmics

NCT02439658 | Unknown

• 2 other identifiers: 2013P0018515R01HL143070
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 5

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

Keywords

genetic research

Outcome Measures

Primary Outcomes (1)

• QT interval

  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 Outcomes (1)

• Successful drug initiation

  Patient will be followed for the duration of the hospitalization, which is on average 3 days

Study Arms (2)

Dofetilide patients

Patients admitted for dofetilide initiation

Drug: Dofetilide and/or sotalol

Sotalol patients

Patients admitted for sotalol initiation

Drug: Dofetilide and/or sotalol

Interventions

Dofetilide and/or sotalol DRUG

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.

Also known as: Tikosyn

Dofetilide patients; Sotalol patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients admitted for dovetailed or sotalol initiation for clinical purposes.

You may qualify if:

• All patients admitted for dovetailed or sotalol initiation for clinical purposes.

You may not qualify if:

• Inability to provide informed consent
• Inability to provide blood samples for DNA testing (anemia, coagulopathy)

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Mayo Clinic: collaborator
• The Cleveland Clinic: collaborator
• University of Colorado, Denver: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (5)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

COMPLETED

Mayo Clinic

Rochester, Minnesota, 55902, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for DNA extraction

MeSH Terms

Conditions

Long QT Syndrome; Drug-Related Side Effects and Adverse Reactions

Interventions

dofetilide

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders

Study Officials

• Christopher Newton-Cheh, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Newton-Cheh, MD, MPH

CONTACT

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

Elizabeth Farland, BS

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Overall Principal Investigator

Study Record Dates

• First Submitted: May 5, 2015
• First Posted: May 12, 2015
• Study Start: January 1, 2014
• Primary Completion: December 31, 2022
• Study Completion: April 30, 2023
• Last Updated: April 4, 2022

Record last verified: 2022-03

Locations

US (5)