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New Formulations of Propafenone to Treat Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT02710669
Recruitment Status : Recruiting
First Posted : March 17, 2016
Last Update Posted : September 28, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Bjorn Knollmann, Vanderbilt University

Brief Summary:
Propafenone is a currently used medicine to treat atrial fibrillation and is a mixture of two compounds, (R)-propafenone and (S)-propafenone. In this study, the investigators will randomize participants to (R)-propafenone, (S)-propafenone, or placebo.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: (R)-propafenone Drug: (S)-Propafenone Drug: Placebo Phase 1 Phase 2

Detailed Description:
Atrial fibrillation is a common cardiac arrhythmia that needs development of more effective medications. Propafenone is a medicine currently used to treat atrial fibrillation and is a mixture of two compounds, (R)-propafenone and (S)-propafenone. The investigators have discovered that purified (R)-propafenone may be more effective than (S)-propafenone for treatment of atrial fibrillation, and that (S)-propafenone reduces the efficacy of (R)-propafenone when administered as a mixture. This study will compare the ability of (R)-propafenone, (S)-propafenone, and placebo to suppress the induction of atrial fibrillation in participants undergoing an atrial fibrillation ablation procedure.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 243 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of (R) and (S) Propafenone for Prevention of Atrial Fibrillation Induction
Study Start Date : October 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: (R)-propafenone
Single intravenous dose of (R)-propafenone (2mg/kg) infused over 10 minutes
Drug: (R)-propafenone
Active Comparator: (S)-Propafenone
Single intravenous dose of (S)-propafenone (2mg/kg) infused over 10 minutes
Drug: (S)-Propafenone
Placebo Comparator: Placebo
Placebo (normal saline) is infused over 10 minutes
Drug: Placebo



Primary Outcome Measures :
  1. Induction of atrial fibrillation (yes or no) [ Time Frame: intraoperative ]
    A rapid atrial pacing protocol will be used to attempt to induce atrial fibrillation



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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:

  1. History of atrial fibrillation
  2. Greater than or equal to 18 years of age
  3. Scheduled to undergo an atrial fibrillation ablation procedure
  4. Able to provide written informed consent

Exclusion:

  1. Long-standing persistent atrial fibrillation at the time of ablation (greater than 1 year of a continuous atrial fibrillation episode)
  2. Is in atrial fibrillation or atrial flutter the morning of the ablation procedure
  3. The presence of any of the following in a patient without a permanent pacemaker for implantable cardiac defibrillator

    1. sick sinus syndrome indicated by the inability to previously tolerate an antiarrhythmic drug due to bradycardia
    2. sinus bradycardia with a heart rate less than 50 beats per minute at the time of study drug administration
    3. right bundle branch block, left bundle branch block, or bifascicular block
    4. PR-interval > 280ms, or history of 2nd or 3rd degree atrioventricular block
  4. Concomitant use of CYP3A4 and CYP2D6 inhibitors
  5. Previous surgical or catheter ablation for atrial fibrillation or Cox-Maze procedure
  6. Amiodarone use within 3 months prior to enrollment
  7. Antiarrhythmic drug (other than amiodarone) within 5 half-lives prior to atrial fibrillation ablation
  8. Expected life span < 1 year
  9. Creatinine clearance <30 mL/min
  10. Reversible cause of atrial fibrillation (ie. thyrotoxicosis)
  11. Unrevascularized coronary artery disease
  12. Canadian class IV angina
  13. Left ventricular ejection fraction <40%
  14. New York Heart Association Class III or IV symptoms
  15. Previous heart transplantation
  16. Planned heart transplantation or ventricular assist device
  17. Cardiac/thoracic surgery <6 months prior to enrollment
  18. Severe asthma or chronic obstructive pulmonary disease
  19. Breastfeeding

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): NCT02710669


Contacts
Contact: Diane M Crawford, RN 615-322-3304 diane.m.crawford@vumc.org
Contact: Ben Shoemaker, MD 615-875-9730 moore.b.shoemaker@vumc.org

Locations
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Bjorn Knollmann, MD/PhD Vanderbilt University
Study Director: Ben Shoemaker, MD Vanderbilt University

Publications:
Responsible Party: Bjorn Knollmann, Professor of Medicine and Pharmacology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02710669     History of Changes
Other Study ID Numbers: 151952
1R01HL124935-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Bjorn Knollmann, Vanderbilt University:
ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Propafenone
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action