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Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT02347111
Recruitment Status : Recruiting
First Posted : January 27, 2015
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Dawood Darbar, University of Illinois at Chicago

Brief Summary:
In this pilot and feasibility study, the investigators will enroll patients with frequent symptomatic episodes of atrial fibrillation (AF) in a cross-over study testing two different classes of anti arrhythmic drugs (AADs). This pilot and feasibility study will provide preliminary data for a larger study in which the investigators will test the hypothesis that a common AF genetic risk allele modulates response to different AADs.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Flecainide Drug: Sotalol Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot and Feasibility Study to Determine if a Common Atrial Fibrillation Risk Locus Modulates Differential Response to Antiarrhythmic Drugs
Study Start Date : February 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: flecainide 1st
flecainide x 6 months, then crossover to sotalol x 6 months
Drug: Flecainide
flecainide up to 150mg twice daily for the control of atrial fibrillation

Drug: Sotalol
sotalol up to 120mg twice daily for the control of atrial fibrillation

Experimental: sotalol 1st
sotalol x 6 months, then crossover to flecainide x 6 months
Drug: Flecainide
flecainide up to 150mg twice daily for the control of atrial fibrillation

Drug: Sotalol
sotalol up to 120mg twice daily for the control of atrial fibrillation




Primary Outcome Measures :
  1. AF burden (Percent of time subject is in atrial fibrillation) [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All races/ethnicities ≥ 18 years of age
  • History of typical or lone symptomatic AF
  • AF symptoms present at least once per month
  • ECG that was recorded within 12 months of randomization showing AF
  • Starting a Class I or Class III AAD
  • In sinus rhythm at enrollment
  • Able to give informed consent

Exclusion Criteria:

  • Permanent AF or isolated atrial flutter.
  • Cardiac or thoracic surgery within the previous 6 months
  • Previous use of amiodarone other than short-term use (e.g. for an acute arrhythmia in hospital)
  • Medical condition that is likely to be fatal in less than one year
  • Received 2 or more AADs in past
  • Creatinine clearance <40 ml/min
  • Contra-indication to a class I AAD e.g., structural heart disease, or history of MI
  • Contra-indication to a class III AAD, e.g., congenital or acquired long QT syndrome with QTc>450 ms at baseline
  • A reversible cause of AF (e.g., thyrotoxicosis)
  • Previously treated with class I and class III antiarrhythmic drugs
  • Females who are pregnant or nursing.
  • History of severe AV node dysfunction unless an electronic pacemaker is present
  • Any race other than Caucasian
  • First- or second-degree relative has already participated in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02347111


Contacts
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Contact: Dawood Darbar, M.D. 6158879032 darbar@uic.edu

Locations
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United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Dawood J Darbar, M.D.    615-887-9032    darbar@uic.edu   
Principal Investigator: Dawood Darbar, M.D.         
Sponsors and Collaborators
University of Illinois at Chicago
Medtronic

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Responsible Party: Dawood Darbar, Professor of Medicine, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02347111     History of Changes
Other Study ID Numbers: VR9644
First Posted: January 27, 2015    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Flecainide
Sotalol
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents