Study with HSY244 to restore normal heart rhythm in people with atrial fibrillatio

Phase 1

• Conditions: Atrial Fibrillation; MedDRA version: 20.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-004327-17-DE
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-02
• Study Completion: 2022-07-11
• Last Update Posted: 6 November 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

1. At screening, written informed consent must be obtained before any
assessment is performed. Only participants able to provide written
informed consent themselves will be included in this study.
2. Hemodynamically stable men and women between 18 and 80 years of
age inclusive at screening with a clinical indication for direct current
cardioversion of Atrial Fibrillation.
3. At screening, current episode of AF has been ongoing for =6 hours and
=60 days
4. Successful initiation and achievement of therapeutic levels of national
guideline and institution-specific anticoagulation therapy as appropriate
for the duration of the Atrial Fibrillation episode and risk for the
participant.
5. Completion of national guideline and institution-specific imaging
evaluation for left atrial thrombi as appropriate for the duration of Atrial
Fibrillation episode and risk for the participant.
6. At screening, 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
7. At screening, vital signs (systolic blood pressure and pulse rate) will
be assessed in the sitting position. Sitting vital signs should 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
8. Able to communicate well with the investigator, to understand and
comply with the requirements of the study.
Other inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1. Women of child-bearing potential unless they are using highly effective methods of contraception
2. Pregnant or nursing (lactating) women.
3. Sexually active males unwilling to use a condom during intercourse
4. Use of a QT prolonging drug within 5 half-lives before randomization
5. History or current diagnosis of ECG abnormalities or cardiac rhythm disorders
6. Clinically significant sinus node dysfunction and/or presence of a permanent pacemaker.
7. Attempted or unsuccessful cardioversion within 2 weeks prior to randomization
8. History of 2 or more ablation procedures for Atrial Fibrillation
9. Presence of a left atrial thrombus that may pose a risk of embolization with cardioversion
10. Presence of known severe mitral regurgitation and/or known severely dilated left atrium.
11. Pre-existing or tachycardia-induced moderate to severe cardiac dysfunction (New York Heart Association Class III and IV).
12. History within the preceding 3 months prior to randomization of: myocardial infarction, unstable angina, cardiac surgery, or a percutaneous coronary intervention.
13. History of a confirmed stroke or transient ischemic attack (TIA).
14. History or current diagnosis of any seizure disorder, epilepsy, significant head trauma, or other disorders increasing the risk for seizures.
15. 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.
16. Moderately or greater impaired renal function
17. Liver disease or liver injury
18. Donation or loss of 450 mL or more of blood within eight weeks prior to randomization, or longer if required by local regulation.
19. Have any other conditions which, in the opinion of the Investigator, would make the patient unsuitable for inclusion or could interfere with the patient participating in or completing the study
20. Significant illness and/or infection which has not resolved within two (2) weeks prior to randomization.

Other exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified