NCT01970501

Genetically Targeted Therapy for the Prevention of Symptomatic Atrial Fibrillation in Patients With Heart Failure

GENETIC-AF - A Genotype-Directed Comparative Effectiveness Trial of Bucindolol and Toprol-XL for Prevention of Symptomatic Atrial Fibrillation/Atrial Flutter in Patients With Heart Failure

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 267 (actual)
• Sponsor: ARCA Biopharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to compare the effects of bucindolol hydrochloride (bucindolol) to metoprolol succinate (Toprol-XL) on the recurrence of symptomatic atrial fibrillation/atrial flutter in patients with heart failure who have a specific genotype for the beta-1 adrenergic receptor.

Detailed description

The goal of the GENETIC-AF trial is to demonstrate the superiority of pharmacogenetically targeted bucindolol compared to metoprolol for the prevention of symptomatic atrial fibrillation or atrial flutter in a genotype-defined population with heart failure and/or reduced left ventricular ejection fraction at high risk of atrial fibrillation/atrial flutter recurrence.

Conditions

• Current or Recent History of Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	bucindolol hydrochloride
DRUG	metoprolol succinate
OTHER	Placebo oral capsule

Timeline

• Start date: 2014-04-01
• Primary completion: 2017-12-28
• Completion: 2017-12-28
• First posted: 2013-10-28
• Last updated: 2022-09-26
• Results posted: 2022-09-15

Locations

97 sites across 6 countries: United States, Canada, Hungary, Netherlands, Poland, Serbia