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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000427

Enrollment

400

Registered

2006-07-10

Start date

2006-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation with Hypertension

Interventions

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)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients entering this study need to meet both of the following criteria: (1) a history of paroxysmal AF within 6 months, and (2) hypertension, defined as a systolic blood pressure (BP) > 140 mmHg and/or a diastolic BP > 90 mmHg. Paroxysmal AF should be a spontaneously terminating episode demonstrated on ECG.

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
(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	—

Measure

Time frame

(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

—

Countries

Japan

Contacts

Public ContactTakeshi Yamashita

The Cardiovascular Institute J-RHYTHM II Clinical Trial Center

j-rhythm2@cvi.or.jp

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026