RECRUITING

Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation

Talk to us

Conditions

Atrial Fibrillation

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Prospective, Multi-Center, Randomized, Open Label Trial to Determine if a Common Atrial Fibrillation Risk Locus Modulates Differential Response to Antiarrhythmic Drugs

Quick Facts

Study Start:2020-12-31
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02347111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥ 18 years of age
  2. * History of typical or early-onset symptomatic (≥2 episodes/month) paroxysmal/persistent AF
  3. * ECG that was recorded within 1 month of randomization showing AF
  4. * Eligible for both Flecainide(Class I) and Sotalol (Class III) AAD
  5. * Able to give informed consent
  1. * Permanent AF or isolated atrial flutter
  2. * Cardiac or thoracic surgery within the previous 6 months
  3. * Previous use of amiodarone other than short-term use (e.g. for an acute arrhythmia in hospital)
  4. * Medical condition that is likely to be fatal in less than one year
  5. * A history of prior AF ablation
  6. * Have already been tried on 2 or more AADs in the past for AF
  7. * Creatinine clearance \<40 ml/min
  8. * Left ventricular ejection fraction \< 50%
  9. * Contra-indication to a Class I AAD e.g., structural heart disease, or history of MI
  10. * Contra-indication to a Class III AAD, e.g., congenital or acquired long QT syndrome with QTc\>480 ms in females and \>460 ms in males at baseline
  11. * A reversible cause of AF (e.g., hyperthyroidism)
  12. * Females who are pregnant or nursing
  13. * History of severe AV node dysfunction unless an electronic pacemaker is present
  14. * First- or second-degree relative has already participated in the study
  15. * Unable to adhere to study procedures that are strictly for research purposes

Contacts and Locations

Study Contact

Dawood Darbar, M.D.
CONTACT
6158879032
darbar@uic.edu

Study Locations (Sites)

Jesse Brown VA Medical Center
Chicago, Illinois, 60612
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
University of Illinois at Chicago
Chicago, Illinois, 60612
United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
United States

Collaborators and Investigators

Sponsor: University of Illinois at Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-31
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2020-12-31
Study Completion Date2025-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Atrial Fibrillation