NIPH Clinical Trials Search

UMIN ID: C000000427

Registered date:10/07/2006

A Randomized Study of Angiotensin II Type 1 Receptor Blocker vs Dihydropidine Ca Antagonist for Treatment of Paroxysmal Atrial Fibrillation in Patients with Hypertension

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedAtrial Fibrillation with Hypertension
Date of first enrollment2006/10/01
Target sample size400
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)ARB Group: candesartan will be prescribed with an initial dose of 8 mg/day (maximal dose 12 mg/day) CCB Group: amlodipine will be prescribed with an initial dose of 2.5 mg/day (maximal dose 5 mg/day)


Primary Outcomethe difference in the number of days with symptomatic and asymptomatic AF recorded on transtelephonic monitoring during the last 1 month of a 1-year follow-up between candesartan and amlodipine groups
Secondary Outcome(1) cardiovascular events, which include cardiac death, myocardial infarction, cerebral infarction, and congestive heart failure or major bleeding requiring hospitalization (2) the development of paroxysmal AF into persistent AF lasting 7days or more, and/or requiring electrical conversion (3) quality of life assessed by the AFQLQ (Atrial Fibrillation specific Quality of Life Questionnaire) (4) left atrial dimension in ultrasound echocardiography (5) the number of days with symptomatic TTM-recorded AF (6) the time-course of the number of days with TTM-recorded AF per month after entering the study

Key inclusion & exclusion criteria

Age minimum18years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteriaThe exclusion criteria are (1) normal BP (systolic/diastolic BP < 140/90 mmHg), (2) a history of vasospastic angina pectoris, (3) persistent AF with a duration of 1 week or longer, and/or permanent AF, (4) AF that has occurred within 1 month of the onset of myocardial infarction, (5) transient AF associated with cardiac surgery, (6) contraindication for anticoagulation therapy, (7) pregnancy or the possibility of pregnancy, and breast feeding, (8) patient age of 18 or less, and (9) a judgment by the attending physician that patient participation would be inappropriate

Related Information


public contact
Name Takeshi Yamashita
Address 7-3-10, Roppongi, Minato-ku, Tokyo Japan
Affiliation The Cardiovascular Institute J-RHYTHM II Clinical Trial Center
scientific contact
Name Satoshi Ogawa
Address 35 Shinanomachi,Shinjuku-ku,Tokyo Japan
Affiliation Keio University School of Medicine Department of Internal Medicine