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

Phase 3

• Conditions: Health Condition 1: I48- Atrial fibrillation and flutter

• Registration Number: CTRI/2013/12/004238
• Lead Sponsor: Zuventus Healthcare Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 0

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 <60 days.

4.Patients developing Atrial Fibrillation or Flutter post cardiac surgery (1-7 days after surgery).

5.Corrected QT interval (QTc) <=440 ms on a 12 lead electrocardiogram (ECG).

6.Haemodynamic stability (systolic blood pressure >=90 mm Hg and diastolic blood pressure >=60 mm Hg and < 105 mm Hg).

7.Ventricular rate >60bpm

Exclusion Criteria

1.History of Hyperthyroidism.

2.Heart Rate <60 bpm.

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 < 40%

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 < 30ml/min.

16.Known hypersensitivity to investigational drug or its components.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients achieving cardio version after intravenous administration of Ibutilide.Timepoint: 72 hours

Secondary Outcome Measures

Name	Time	Method
Adverse events observed during the treatment periodTimepoint: 72 hours