A clinical study to determine the effectiveness and safety of a new drug Ibutilide in the management of rhythm disorders of the heart.

An open, multicentric prospective clinical trial to evaluate the efficacy and safety of Ibutilide fumarate injection in the treatment of Atrial Fibrillation or Flutter.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/12/004238

Enrollment

120

Registered

2013-12-23

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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 Fumarate 0.1mg/ml: Ibutilide Fumarate given intravenously Intervention2: Ibutilide Fumarate Injection 0.1mg/ml: 1 mg infused over 10 min (administered once during the entire s

Eligibility

Inclusion criteria

Inclusion criteria: 1.Above 18 yrs of age, with no previous exposure to investigational drug. 2.Weighing > 60 kg 3.Patients with sustained Atrial Fibrillation or Flutter lasting for >1hr to 4.Patients developing Atrial Fibrillation or Flutter post cardiac surgery (1-7 days after surgery). 5.Corrected QT interval (QTc) 6.Haemodynamic stability (systolic blood pressure >=90 mm Hg and diastolic blood pressure >=60 mm Hg and 7.Ventricular rate >60bpm

Exclusion criteria

Exclusion criteria: 1.History of Hyperthyroidism. 2.Heart Rate 3.History or evidence of unstable angina pectoris, bronchospastic disease or myocardial infarction. 4.Known sinus node dysfunction, second or third degree atrioventricular (AV) block, bundle branch block, Wolff-Parkinson-White syndrome and/or torsade de pointes. 5.Concurrent treatment with verapamil, diltiazem, or drugs that prolong the QT interval 6.Recent major hemorrhage (within 6 months). 7.Coagulopathy 8.Pregnant or breast feeding 9.Acute congestive heart failure 10.Hypokalemia or hyperkalemia (Electrolyte abnormalities) 11.Polymorphic ventricular tachycardia secondary to antiarrhythmic class III and class I 12.Left ventricular ejection fraction 13.Serum creatinine levels >2.5mg/dL 14.Liver function test > 2 times the upper limit of normal value 15.History of chronic renal failure or a creatinine clearance of 16.Known hypersensitivity to investigational drug or its components.

Design outcomes

Primary

Measure	Time frame
Proportion of patients achieving cardio version after intravenous administration of Ibutilide.Timepoint: 72 hours	—

Secondary

Measure	Time frame
Adverse events observed during the treatment periodTimepoint: 72 hours	—

Countries

India

Contacts

Public ContactDr Bhupesh Dewan

Zuventus Healthcare Ltd

bhupesh.dewan@zuventus.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026