Clinical trial NCT01748253: ARB and CCB Longest Combination Treatment on Ambulatory and Home BP in Hypertension With Atrial Fibrillation -Multicenter Study on Time of Dosing (ACROBAT)
Official title: ARB and CCB Longest Combination Treatment on Ambulatory and Home BP in Hypertension With Atrial Fibrillation -Multicenter Study on Time of Dosing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension and Atrial Fibrillation
Lead sponsor: Acrobat Trial Group
Sponsor class: NETWORK
First posted: 2012-12-12
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of 24-hour antihypertensive effect of long-acting ARB-CCB tablet administrated to hypertensive patients with atrial fibrillation, and comparison of 24-hour antihypertensive effect of long-acting ARB-CCB tablet between morning administration and bedtime administration.


Eligibility criteria: Inclusion Criteria:

1. 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 \[4 measurements per day in total: 2 in the morning and 2 before bedtime\])
2. Patients with atrial fibrillation detected on an electrocardiogram within the last 2 years prior to obtaining informed consent.
3. Age: 20 years old or older (at time of informed consent)
4. Sex: male or female
5. Clinical classification: Outpatient
6. Patients who give written consent of agreement to voluntarily participate in the clinical study.

Exclusion Criteria:

1. Patients with serious liver and/or kidney disease
2. Patients with history of allergy to telmisartan or amlodipine
3. Patients receiving antihypertensives other than telmisartan or amlodipine during observation period
4. Patients diagnosed with persistent atrial fibrillation or chronic (permanent) atrial fibrillation.
5. Patients with atrial fibrillation caused by irreversible illness (e.g., heart surgery, pulmonary embolism, or hyperthyroidism)
6. Patients with average systolic blood pressure at hospital visit higher than 180 mmHg during observation period.
7. 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.
8. Patients who have stroke or cardiac infarction within 6 months before giving consent.
9. Patients planning to undergo pulmonary artery ablation surgery or any surgical procedure (including PCI).
10. Patients who are breast-feeding, pregnant, possibly pregnant, or plan to become pregnant.
11. In addition, patients who are determined as not eligible by their study doctor.

Primary outcomes:
measure: Change in 24-hour average blood pressure from baseline to Week 12.
timeFrame: Baseline and 12 weeks.
Secondary outcomes:
measure: Change in blood pressures at night time, early-morning, and daytime from baseline to Week 12.
timeFrame: Baseline and 12 weeks.
measure: Change in blood pressure at hospital visit from baseline to Week 12.
timeFrame: Baseline and 12 weeks.
measure: Change in blood pressure at home from baseline to Week 12.
timeFrame: Baseline and 12 weeks.
measure: Change in blood pressure control rate from baseline to Week 12.
timeFrame: Baseline and 12 weeks.
measure: Change in blood pressure variability from baseline to Week 12.
timeFrame: Baseline and 12 weeks.
measure: Change in laboratory parameters (blood insulin, hsTnT, PAI-1, and NT-ProBNP) from baseline to Week 12.
timeFrame: Baseline and 12 weeks.
measure: Onset of Adverse events
timeFrame: Baseline and 12 weeks.
measure: Onset of atrial fibrillation
timeFrame: Baseline and 12 weeks.
measure: Pulse rate
timeFrame: Baseline and 12 weeks.
measure: PWV value
timeFrame: Baseline and 12 weeks.
measure: Clinical laboratory test results
timeFrame: Baseline and 12 weeks.
Other outcomes:
Locations:
city: Joetsu city
country: Japan
facility: Uchiyama Clinic
state: Niigata pref.
Study officials:
affiliation: Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine
name: Kazuomi Kario
role: STUDY_CHAIR
References:
citation: Kario K, Hoshide S, Uchiyama K, Yoshida T, Okazaki O, Noshiro T, Aoki H, Mizuno H, Matsumoto Y. Dose Timing of an Angiotensin II Receptor Blocker/Calcium Channel Blocker Combination in Hypertensive Patients With Paroxysmal Atrial Fibrillation. J Clin Hypertens (Greenwich). 2016 Oct;18(10):1036-1044. doi: 10.1111/jch.12814. Epub 2016 Mar 16.