Atrial Fibrillation Clinical Trial
Official title:
A Randomized, Placebo-controlled, Investigator- and Participant-blinded Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of HSY244 in Participants With Atrial Fibrillation
Verified date | June 2024 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Terminated |
Enrollment | 13 |
Est. completion date | July 11, 2022 |
Est. primary completion date | July 11, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Key Inclusion Criteria: - At screening, written informed consent were required to be obtained before any assessment was performed and only participants able to provide written informed consent themselves were included in this study. - Hemodynamically stable men and women (either of non-child-bearing potential or child bearing potential with highly effective contraception) between 18 and 80 years of age (inclusive) at screening with a clinical indication for direct current cardioversion of AF. - At screening, current episode of AF had 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. - At screening, participants were required to weigh at least 60 kg to participate in the study and were required to have a body mass index (BMI) within the range of 18 - 45 kg/m^2. BMI = Body weight (kg) / [Height (m)]^2 - At screening, vital signs (systolic blood pressure and pulse rate) were assessed in the sitting position. Sitting vital signs were required to be within the following ranges (exclusive): - systolic blood pressure between 100-160 mmHg and diastolic blood pressure 60-100 mmHg - pulse rate (ventricular rate) between 60-120 bpm. Key Exclusion Criteria: - Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they were using highly effective methods of contraception during dosing and for 4 days after stopping of investigational drug. - Sexually active males unwilling to use a condom during intercourse while taking investigational drug and for 96 hours after study drug administration. A condom was required for all sexually active male participants to prevent them from fathering a child AND to prevent delivery of the investigational drug via seminal fluid to their partner. In addition, male participants could not donate sperm for the time period specified above. - Use of any anti-arrhythmic class I or III drug (including Ranolazine [Ranexa]) within 5 half lives before randomization; including use of amiodarone within 3 months before randomization. - At screening, history of current diagnosis of ECG abnormalities or cardiac rhythm disorders as determined by the Investigator's interpretation of the ECG findings indicating a significant risk for participating in the study, such as: - History of Torsades de Pointes (TdP), any other polymorphic ventricular tachycardia, sustained monomorphic ventricular tachycardia, long QT syndrome, or Brugada syndrome. - Wolfe-Parkinson-White (WPW) syndrome - In the absence of a complete bundle branch block a resting QTcF >460 msec for men and >470 msec for women (mean of = 5 consecutive QT intervals) - In the presence of a complete bundle branch block, a prolonged QTcF or JTc that, in the opinion of the investigator, may pose a risk to patient safety - Third-degree (complete) heart block, or second-degree Mobitz type II heart block - 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 and IV). - History within the preceding 3 months prior to randomization of: myocardial infarction, unstable angina, cardiac surgery, or a percutaneous coronary intervention. - History of a confirmed stroke or transient ischemic attack (TIA). - History or current diagnosis of any seizure disorder, epilepsy, significant head trauma, or other disorders increasing the risk for seizures. - History or current diagnosis of a major neurologic or psychiatric disorder that, in the opinion of the investigator, poses a risk to patient safety to participate. |
Country | Name | City | State |
---|---|---|---|
Germany | Novartis Investigative Site | Bad Oeynhausen | |
Germany | Novartis Investigative Site | Frankfurt | |
United States | Novartis Investigative Site | Boston | Massachusetts |
United States | Novartis Investigative Site | Lansing | Michigan |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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'. |
90 minutes from the start of study drug administration | |
Secondary | 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. |
Day 1 (0 min (pre-dose), 15 min (end of infusion), 30 min , 60 min, 90 min and 180 min) and Day 5 | |
Secondary | 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. |
Day 1 (0 min (pre-dose), 15 min (end of infusion), 30 min , 60 min, 90 min and 180 min) and Day 5 | |
Secondary | 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. |
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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