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 - GENETIC-AF

ARCA biopharma, Inc.0 sites620 target enrollmentAugust 17, 2016

Overview

No summary available.

Registry

who.int

Start Date

August 17, 2016

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Patients must meet all of the following inclusion criteria to be eligible for randomization in this study.
•1\. Age \= 18 years and \= 85 years at the Screening Visit.
•2\. Weight \= 40 kg at the Randomization Visit.
•3\. Possess the ß1389Arg/Arg genotype.
•4\. History of heart failure with reduced left ventricle ejection fraction (HFREF).
•a. LVEF \< 0\.50 assessed at any time during the previous 12 months of the Screening Visit.
•5\. At least one symptomatic paroxysmal or persistent AF episode \= 180 days of the Screening Visit.
•a. Qualifying AF episode may be documented by ECG, Holter, TTM, or implanted device. AF documented by implanted device must be a single episode \= 60 minutes in duration. Atrial flutter is not considered a qualifying AF episode.
•b. Must have experienced AF symptoms \= 180 days of the Screening Visit, but these symptoms may overlap with HF symptoms, i.e. may be arrhythmic” (e.g. palpitations, dizziness) or heart failure” (e.g. breathlessness, fatigability) in nature.
•6\. Clinically appropriate for ECV if AF/AFL is present at the Week 0 Visit, including:

•1\. NYHA Class IV symptoms at the Randomization Visit.
•2\. Significant fluid overload at the Randomization Visit, in the opinion of the Investigator. Evidence of significant fluid overload may include:
•a. Mean jugular venous pressure above the clavicle at 90°.
•b. Liver congestion.
•c. Moist pulmonary rales post\-cough.
•d. Peripheral edema beyond 1\+ pedal not explained by local factors.
•3\. Permanent AF at the Screening Visit.
•a. Permanent AF is defined as an ongoing AF event 1 year or longer in duration in which there is no intervening evidence of SR.
•4\. More than two ECV procedures within 6 months of the Randomization Visit or if the most recent ECV within 6 months of the Randomization Visit failed to produce SR.
•5\. Use of any of the following \< 7 days of the randomization Visit: