This was a randomized, placebo-controlled, investigator- and participant-blinded study to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of HSY244 in participants with atrial fibrillation (AF), with and without heart failure (HF).
A screening period of up to 3 days (72 hours) was used to assess eligibility. After eligibility was confirmed, patients were randomized to either HSY244 or placebo. Prior to study drug administration, pre-dose assessments were completed. After the start of study drug administration, the participant was monitored for cardioversion to sinus rhythm. If a participant was still in AF at 90 minutes after the start of study drug administration, direct current cardioversion was planned to be applied at a time deemed appropriate by the investigator.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
13
Novartis Investigative Site
Boston, Massachusetts, United States
Novartis Investigative Site
Lansing, Michigan, United States
Novartis Investigative Site
Bad Oeynhausen, Germany
Novartis Investigative Site
Frankfurt, Germany
Number of Participants With Conversion to Sinus Rhythm for at Least 1 Minute Within 90 Minutes From the Start of Study Drug Administration.
Conversion to sinus rhythm was monitored using a Holter monitoring device through 90 minutes after the start of study drug administration. If a participant had been monitored for at least 45 minutes and did not convert to sinus rhythm for at least one minute, the primary endpoint was defined as 'no'. If a participant converted to sinus rhythm for at least one minute at any time during the post-treatment 90 minutes observation period, regardless of the length of time monitored, the primary endpoint was to be defined as 'yes'.
Time frame: 90 minutes from the start of study drug administration
Maximum Observed Plasma Concentration (Cmax)
The Cmax is the maximum (peak) observed plasma drug concentration after single-dose administration. Actual recorded sampling times were taken into consideration for PK calculations.
Time frame: Day 1 (0 min (pre-dose), 15 min (end of infusion), 30 min , 60 min, 90 min and 180 min) and Day 5
Time to Reach the Maximum Concentration After Drug Administration (Tmax)
Tmax is the time to reach maximum (peak) plasma drug concentration after single dose administration (time). Actual recorded sampling times were taken into consideration for PK calculations.
Time frame: Day 1 (0 min (pre-dose), 15 min (end of infusion), 30 min , 60 min, 90 min and 180 min) and Day 5
Area Under the Plasma Concentration-time Curve (AUClast)
AUClast is the AUC from time zero to the last measurable concentration sampling time (tlast). Actual recorded sampling times were taken into consideration for PK calculations.
Time frame: Day 1 (0 min (pre-dose), 15 min (end of infusion), 30 min , 60 min, 90 min and 180 min) and Day 5
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