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

A Randomized, Placebo-controlled, Investigator- and Participant-blinded Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of HSY244 in Participants With Atrial Fibrillation

ClinicalTrials.gov Identifier: NCT04582409

Novartis Reference Number: CHSY244X2201

Last Update: Sep 22, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics of HSY244 in participants with atrial fibrillation (AF), with and without heart failure (HF).

Condition 
Atrial Fibrillation
Phase 
Phase 2
Overall status 
Recruiting
Start date 
Nov 30, 2020
Completion date 
Nov 08, 2022
Gender 
All
Age(s)
18 Years - 80 Years (Adult, Older Adult)

Interventions

Drug
HSY244
HSY244 concentrate solution for injection via intravenous infusion
Other
Placebo
Placebo concentrate solution for injection via intravenous infusion

Eligibility Criteria

Key Inclusion Criteria:

Hemodynamically stable men and women between 18 and 80 years of age with a clinical indication for direct current cardioversion of AF
Current episode of AF has been ongoing for >= 6 hours and =< 60 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 - 45 kg/m2. BMI = Body weight (kg) / [Height (m)2]
Written informed consent must be obtained before any assessment is performed and only participants able to provide written informed consent themselves will be included in this study

Key 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
Attempted or unsuccessful cardioversion within 2 weeks prior to randomization
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 96 hours 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

Study Locations

United States
Novartis Investigative Site
Recruiting
Chicago, 60612
Illinois
United States
Novartis Investigative Site
Recruiting
Boston, 02115
Massachusetts
United States
Novartis Investigative Site
Recruiting
Boston, 02215
Massachusetts
United States
Novartis Investigative Site
Recruiting
Lansing, 48912
Michigan
United States
Novartis Investigative Site
Recruiting
Brooklyn, 11235-7745
New York
United States
Novartis Investigative Site
Recruiting
New York, 10032
New York
United States
Novartis Investigative Site
Recruiting
Hershey, 17033
Pennsylvania
United States
Germany
Novartis Investigative Site
Recruiting
Bad Berka, 99437
-
Germany
Novartis Investigative Site
Recruiting
Bad Oeynhausen, 32545
-
Germany
Novartis Investigative Site
Recruiting
Frankfurt, 60590
-
Germany
Novartis Investigative Site
Recruiting
Leipzig, 04103
-
Germany
Novartis Investigative Site
Recruiting
Ulm, 89081
-
Germany

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]