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determination of efficacy and safety of Ibutilde in patients with abnormal heart rythm

An Open-Label, Multicentre, Prospective, Phase- IV Study to Evaluate the Efficacy and Safety of Ibutilide Fumarate Injection (0.1mg/ml) in the Treatment of Atrial Fibrillation and Flutter - IBUTILIDE PHASE IV

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/01/011248
Enrollment
120
Registered
2018-01-10
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I48- Atrial fibrillation and flutter

Interventions

Intervention1: ibutilide: Ibutilide fumarate injection(0.1 mg/mL) 1 mg infused over 10 minutes. Additional 1mg infusion over 10 minutes may be administered after waiting for 10 minutes following the

Sponsors

Zuventus Healthcare Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients >18 yrs of age Patients with sustained Atrial Fibrillation or Flutter lasting for >1hr to Patients developing Atrial Fibrillation or Flutter post cardiac surgery (1-7 days after surgery). Corrected QT interval (QTc) � 440 ms on a 12 lead electrocardiogram (ECG). Haemodynamic stability ( systolic blood pressure � 90 mm Hg and diastolic blood pressure � 60 mm Hg and Absence of structural heart disease Ventricular rate >60bpm

Exclusion criteria

Exclusion criteria: Known hypersensitivity to ibutilide injection or its components like sulphonamides or sulfa drugs. Known sinus node dysfunction, second or third degree atrioventricular (AV) block, bundle branch block and/or torsades de pointes. Patient with documented evidence of atrial clot formation. Severely Anaemic patients (Hb Pregnant or breast feeding Grade III & IV congestive heart failure Serum potassium Severe hepatic, hematologic, metabolic, renal, gastrointestinal, central nervous system, psychiatric, or other disorder that could interfere with the conduct of the study; or compromise safety.

Design outcomes

Primary

MeasureTime frame
To investigate the efficacy of Ibutilide for cardioversion of atrial fibrillation and flutterTimepoint: Proportion of patients achieving cardioversion (sinus rhythm) after intravenous administration of Ibutilide fumarate injection. Mean Time to achieve cardioversion—

Secondary

MeasureTime frame
To evaluate the safety of the Ibutilide in Indian patientsTimepoint: Proportion of patients who remained in sinus rhythm at 24 hours post dose Adverse events observed during the study period—

Countries

India

Contacts

Public ContactDr Bhupesh Dewan

Zuventus Healthcare Ltd

Bhupesh.Dewan@zuventus.com022-30610000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 6, 2026