ARB and CCB Longest Combination Treatment on Ambulatory and Home BP in Hypertension With Atrial Fibrillation -Multicenter Study on Time of Dosing (ACROBAT) (ACROBAT)

ARB and CCB Longest Combination Treatment on Ambulatory and Home BP in Hypertension With Atrial Fibrillation -Multicenter Study on Time of Dosing

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.

Study Overview

• Status: Unknown
• Conditions: Hypertension and Atrial Fibrillation
• Intervention / Treatment: Drug: Telmisartan-amlodipine tablet administration group (morning); Drug: Telmisartan-amlodipine tablet administration group (bedtime)

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shinji Mitoma; Phone Number: +81-3-5312-5026; Email: acrobat-study@sa-tt.co.jp

Study Locations

• Japan
  • Niigata pref.
    • Joetsu city, Niigata pref., Japan
      • Recruiting
      • Uchiyama Clinic
      • Contact: Kazuaki Uchiyama; Phone Number: +81-25-548-2400

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Telmisartan-amlodipine tablet administration group (morning)	Drug: Telmisartan-amlodipine tablet administration group (morning); Oral-administration of one telmisartan-amlodipine tablet once a day upon morning for 12 weeks
ACTIVE_COMPARATOR: Telmisartan-amlodipine tablet administration group (bedtime)	Drug: Telmisartan-amlodipine tablet administration group (bedtime); Oral-administration of one telmisartan-amlodipine tablet once a day at bedtime for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in 24-hour average blood pressure from baseline to Week 12.	Baseline and 12 weeks.

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in blood pressures at night time, early-morning, and daytime from baseline to Week 12.	Baseline and 12 weeks.
Change in blood pressure at hospital visit from baseline to Week 12.	Baseline and 12 weeks.
Change in blood pressure at home from baseline to Week 12.	Baseline and 12 weeks.
Change in blood pressure control rate from baseline to Week 12.	Baseline and 12 weeks.
Change in blood pressure variability from baseline to Week 12.	Baseline and 12 weeks.
Change in laboratory parameters (blood insulin, hsTnT, PAI-1, and NT-ProBNP) from baseline to Week 12.	Baseline and 12 weeks.
Onset of Adverse events	Baseline and 12 weeks.
Onset of atrial fibrillation	Baseline and 12 weeks.
Pulse rate	Baseline and 12 weeks.
PWV value	Baseline and 12 weeks.
Clinical laboratory test results	Baseline and 12 weeks.

Collaborators and Investigators

• Sponsor: Acrobat Trial Group
• Investigators: Study Chair: Kazuomi Kario, Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (ANTICIPATED): October 1, 2013

Study Registration Dates

• First Submitted: November 16, 2012
• First Submitted That Met QC Criteria: December 11, 2012
• First Posted (ESTIMATE): December 12, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): May 21, 2013
• Last Update Submitted That Met QC Criteria: May 20, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arrhythmias, Cardiac; Hypertension; Atrial Fibrillation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Amlodipine; Telmisartan; Telmisartan amlodipine combination
• Other Study ID Numbers: 0067