Clinical study of Landiolol hydrochloride in the treatment of postoperative atrial fibrillation/atrial flutter after cardiovascular surgery

UMIN ID: UMIN000000957

Registered date:27/12/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: tachyarrhythmia
• Date of first enrollment: 2008/01/01
• Target sample size: 400
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intravenous beta-blocker, Landiolol hydrochloride for up to 24 hrs
Intravenous calcium channel blocker, Diltiazem hydrochloride for up to 24 hrs

Outcome(s)

• Primary Outcome: Atrial fibrillation / atrial flutter (heart rate control, converting rate to normal sinus rhythm, palindromia rate)
• Secondary Outcome: Ischemic changes Changes of blood pressure Manifestation rate of bradycardia,atrioventricular block and cardiovascular events Length of ICU and hospitalization Cost of medical care after cardiovascular surgery Mortality rate in nosocomial

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 85years-old
• Gender: Male and Female
• Exclude criteria: (1) acute myocardial infarction within 3 days (2) supraventricular arrhythmia (3) sick sinus syndrome (containing patients with pacemaker) (4) grave heart failure (preoperative NYHA Classification of the Stages of Heart Failure, more than or equal to third degree) (5) atrioventricular block, more than or equal to second degree (6) contraindication to beta-blockers or , calcium channel blockers (7) electrolyte imbalance, WPW syndrome or hyperthyroidism (8) blood pressure < 90/60 mmHg (9) postoperative peroral use of beta-blockers or, calcium channel blockers (10) use of operative and postoperative antiarrhythmic medications excluding Digitalis

Related Information

• Primary Sponsor: JL-Knight Study Group
• Source(s) of Monetary Support: none