determination of efficacy and safety of Ibutilde in patients with abnormal heart rythm
- Conditions
- Health Condition 1: I48- Atrial fibrillation and flutter
- Registration Number
- CTRI/2018/01/011248
- Lead Sponsor
- Zuventus Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
Patients >18 yrs of age
Patients with sustained Atrial Fibrillation or Flutter lasting for >1hr to <90 days.
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 < 105 mm Hg).
Absence of structural heart disease
Ventricular rate >60bpm
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 < 8.0 g/dL)
Pregnant or breast feeding
Grade III & IV congestive heart failure
Serum potassium <3.5 mEq/L or serum magnesium <1.5 mEq/L
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method