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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) studied	Atrial Fibrillation with Hypertension
Date of first enrollment	2006/10/01
Target sample size	400
Countries of recruitment	Japan
Study type	Interventional
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)

TO Original Data: UMIN

Outcome(s)

Primary Outcome	the 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

Primary Outcome

the 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 minimum	18years-old
Age maximum	Not applicable
Gender	Male and Female
Include criteria
Exclude criteria	The 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

Primary Sponsor	The J-RHYTHM II Investigators
Secondary Sponsor
Source(s) of Monetary Support	Japan Heart Foundation
Secondary ID(s)

Contact

public contact
Name	Takeshi Yamashita
Address	7-3-10, Roppongi, Minato-ku, Tokyo Japan
Telephone
E-mail	j-rhythm2@cvi.or.jp
Affiliation	The Cardiovascular Institute J-RHYTHM II Clinical Trial Center
scientific contact
Name	Satoshi Ogawa
Address	35 Shinanomachi,Shinjuku-ku,Tokyo Japan
Telephone
E-mail
Affiliation	Keio University School of Medicine Department of Internal Medicine

TO Original Data: UMIN