Phase II study of prophylactic oral administration of diltiazem for atrial fibrillation after lung resection

UMIN ID: UMIN000001691

Registered date:06/02/2009

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: atrial fibrillation after lung resection
• Date of first enrollment: 2009/01/01
• Target sample size: 124
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Diltiazem 90mg/day from POD 1 to POD 7 Diltiazem 60mg/day from POD 8 to POD 14
Lactose 0.9g/day from POD 1 to POD 7 Lactose 0.6g/day from POD 8 to POD 14

Outcome(s)

• Primary Outcome: Incidence of atrial fibrillation after lung resection
• Secondary Outcome: Degree and frequency of adverse event (hypotension, bradycardia, etc.)

Key inclusion & exclusion criteria

• Age minimum: 45years-old
• Age maximum: 85years-old
• Gender: Male and Female
• Exclude criteria: unstable angina pectoris, myocardial infarction or heart failure with in 3 months uncontrolled diabetes or hypertension active infection gastrointestinal bleeding diarrhea ileus chronic Af already taking diltiazem or other calcium blocker AV block more than 2nd degree sick sinus syndrome past history of severe allergy uncontrolled pleural effusion, ascites or pericardial fluid in pregnancy

Related Information

• Primary Sponsor: Department of Surgical Oncology, Hokkaido University Graduate School of Medicine
• Secondary Sponsor: Teine Keijinkai Hospital Minami Sanjo Hospital
• Source(s) of Monetary Support: Department of Surgical Oncology, Hokkaido University Graduate School of Medicine