A Study to Evaluate the Efficacy Safety Tolerability and Pharmacokinetics of HSY244 in Participants With Atrial Fibrillation

  • STATUS
    Recruiting
  • End date
    Apr 27, 2022
  • participants needed
    40
  • sponsor
    Novartis Pharmaceuticals
Updated on 2 September 2021
body mass index
fibrillation
cardioversion
anticoagulation therapy

Summary

A randomized, placebo-controlled, investigator- and participant-blinded study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of HSY244 in participants with AF.

Description

A randomized, placebo-controlled, investigator- and participant-blinded study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of HSY244 in participants with AF.

Participants will be randomized and assigned to one of the following 2 treatment arms in a ratio of 1:1:

Arm 1: HSY244 intravenous infusion Arm 2: Placebo intravenous infusion

The study consists of a screening period of up to 3 days and a treatment period of 4 days. After confirming eligibility on Day 1 and pre-dose assessments are completed, study administration will occur and participants will be monitored for cardioversion to sinus rhythm. During the treatment period, participants will be evaluated for efficacy, safety, tolerability, and pharmacokinetics.

Details
Condition Arrhythmia, Atrial Fibrillation, Atrial Fibrillation (Pediatric), Dysrhythmia
Treatment Placebo, HSY244
Clinical Study IdentifierNCT04582409
SponsorNovartis Pharmaceuticals
Last Modified on2 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Hemodynamically stable men and women between 18 and 75 years of age with a clinical indication for direct current cardioversion of AF
Current episode of AF has been ongoing for 6 hours and 30 days
Successful initiation and achievement of therapeutic levels of national guideline and institution-specific anticoagulation therapy as appropriate for the duration of the AF episode and risk for the participant
Completion of national guideline and institution-specific imaging evaluation for left atrial thrombi as appropriate for the duration of AF episode and risk for the participant
Participants must weigh at least 60 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 35 kg/2. BMI = Body weight (kg) / [Height (m)2]
Written informed consent must be obtained before any assessment is performed

Exclusion Criteria

Use of any class I or III anti-arrhythmic medication, or other prohibited medications, within 5 half-lives before randomization, including use of amiodarone within 3 months before randomization
History or current diagnosis of electrocardiogram (ECG) abnormalities or cardiac rhythm disorders indicating significant risk of safety for participant as determined by the Investigator's interpretation of the ECG findings
Clinically significant sinus node dysfunction and/or presence of a permanent pacemaker
Attempted or unsuccessful cardioversion within 2 weeks prior to randomization
History of 2 or more ablation procedures for AF
Presence of known severe mitral regurgitation and/or known severely dilated left atrium
Pre-existing or tachycardia-induced moderate to severe cardiac dysfunction (New York Heart Association class III or IV)
History within the preceding 3 months prior to randomization of either a: myocardial infarction, unstable angina, cardiac surgery, or a percutaneous coronary intervention
History of confirmed stroke or transient ischemic attack (TIA)
History or current diagnosis of any seizure disorder or major neurological disorder or major psychiatric disorder
Sexually active males, including those post-vasectomy, must use a condom during sexual intercourse for at least 4 days after dosing to prevent delivery of the drug via seminal fluid and should not father a child during this period
Women must be either of non-childbearing potential or child-bearing potential using highly effective non-hormonal contraception Other protocol-defined inclusion/exclusion may apply
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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