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Research

Photo for GENETIC-AF

GENETIC-AF

Official Title

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

Ongoing

Overview

The purpose of this trial is to determine if pharmacogenetically targeted bucindolol is superior to Toprol-XL for reducing the recurrence of symptomatic atrial fibrillation/atrial flutter (AF/AFL) in a genotype-defined population with heart failure and/or reduced left ventricular ejection fraction (LVEF) and persistent symptomatic AF requiring electrical cardioversion to sinus rhythm.

Study Design

GENETIC-AF is a double-blind, two-arm, genotype-directed, active-controlled, adaptive-design, superiority study.

Primary Endpoint

Time to first event of symptomatic atrial fibrillation/atrial flutter (AF/AFL) or all-cause mortality (ACM) during the 24-week follow-up period after conversion to stable sinus rhythm.

Number of Patients

620

Number of Sites

105

Number of Countries

3

Study Period

2014-2017

Principal Investigator

Jeff Healey

Program Manager

Kimberly Begley

Research Coordinator

Andrea Ling

Collaborators

ARCA biopharma Inc