New Formulations of Propafenone to Treat Atrial Fibrillation
Purpose
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
- Atrial Fibrillation
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- 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
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental (R)-propafenone |
Single intravenous dose of (R)-propafenone (2mg/kg) infused over 10 minutes |
|
|
Active Comparator (S)-Propafenone |
Single intravenous dose of (S)-propafenone (2mg/kg) infused over 10 minutes |
|
|
Placebo Comparator Placebo |
Placebo (normal saline) is infused over 10 minutes |
|
More Details
- Status
- Terminated
- Sponsor
- Vanderbilt University
Study Contact
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.