ARB and CCB Longest Combination Treatment on Ambulatory and Home BP in Hypertension With Atrial Fibrillation -Multicenter Study on Time of Dosing (ACROBAT) (ACROBAT)
Hypertension and Atrial Fibrillation
About this trial
This is an interventional treatment trial for Hypertension and Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
Hypertensive patients who meet the following conditions:
Patients who meet any of the following standards of blood pressure after administration of 40 mg/day telmisartan or 5 mg/day amlodipine for 4 weeks:
- Blood pressure at hospital visit: Systolic blood pressure is 140 mmHg or higher, and/or diastolic blood pressure is 90 mmHg or higher.
(average of 3 measurements obtained at a scheduled visit)
- Blood pressure at home: Systolic blood pressure is 135 mmHg or higher, and/or diastolic blood pressure is 85 mmHg or higher.
(average of measurements for the 5 days prior to drug assignment [4 measurements per day in total: 2 in the morning and 2 before bedtime])
- Patients with atrial fibrillation detected on an electrocardiogram within the last 2 years prior to obtaining informed consent.
- Age: 20 years old or older (at time of informed consent)
- Sex: male or female
- Clinical classification: Outpatient
- Patients who give written consent of agreement to voluntarily participate in the clinical study.
Exclusion Criteria:
- Patients with serious liver and/or kidney disease
- Patients with history of allergy to telmisartan or amlodipine
- Patients receiving antihypertensives other than telmisartan or amlodipine during observation period
- Patients diagnosed with persistent atrial fibrillation or chronic (permanent) atrial fibrillation.
- Patients with atrial fibrillation caused by irreversible illness (e.g., heart surgery, pulmonary embolism, or hyperthyroidism)
- Patients with average systolic blood pressure at hospital visit higher than 180 mmHg during observation period.
- Patients with New York Heart Association (NYHA) class III-IV heart failure, patients with heart failure requiring hospitalization, or patients with poor left ventricular function.
- Patients who have stroke or cardiac infarction within 6 months before giving consent.
- Patients planning to undergo pulmonary artery ablation surgery or any surgical procedure (including PCI).
- Patients who are breast-feeding, pregnant, possibly pregnant, or plan to become pregnant.
- In addition, patients who are determined as not eligible by their study doctor.
Sites / Locations
- Uchiyama ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Telmisartan-amlodipine tablet administration group (morning)
Telmisartan-amlodipine tablet administration group (bedtime)