Comparison of Effect of cARvedilol Compared To bISoprolol on cenTral Pulse Pressure in Hypertension (ARTIST) Study

NCT ID: NCT01243827

Last Updated: 2012-07-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2013-04-30

Brief Summary

The purpose of this study is to compare of carvedilol, a vasodilating beta-blocker and bisoprolol, a beta1- selective beta-blocker for reducing the central pulse pressure and thereby left ventricular (LV) mass in never-treated hypertensive patients.

Detailed Description

Carvedilol and bisoprolol are established beta-blockers for treating hypertension or chronic heart failure because these beta-blockers have cardio-protective effects. Recent studies have shown that the change in central pulse pressure is more closely associated with the change in cardiac load than the change in brachial pressure during hypertension treatment. Vasodilating beta-blockers may decrease central pulse pressure more than beta1- selective beta-blockers, because vasodilators reduced the magnitude of reflection wave by dilating peripheral muscular arteries. The investigators hypothesized that carvedilol, a vasodilating beta-blocker, would be more effective than bisoprolol, a beta1- selective beta-blocker in reducing central pulse pressure and thereby LV mass, through the reduction in the magnitude of reflection wave. The aim of the present study was to test this hypothesis in an active controlled, 2-arm parallel group comparison, prospective randomized open blinded end-point (PROBE) design study. At least 100 patients will be enrolled in each group and the follow up duration will be 48 weeks. The primary endpoint is to compare the change in central pulse pressure between the two groups.

Conditions

Hypertension

Keywords

Hypertension, carvedilol, bisoprolol, central pulse pressure, pulse pressure amplification, reflection magnitude, LV mass index, LV diastolic function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

carvedilol

carvedilol is administered after randomization at a dose of 10 mg once daily, and if needed, titrated to 15 mg and to a maximum of 20 mg to achieve a clinic BP \<140/90 mmHg.

Group Type: EXPERIMENTAL

carvedilol

Intervention Type: DRUG

carvedilol is administered after randomization at a dose of 10 mg once daily, and if needed, titrated to 15 mg and to a maximum of 20 mg to achieve a clinic BP \<140/90 mmHg.

bisoprolol

bisoprolol is administered after randomization at a dose of 2.5 mg once daily, and if needed, titrated to 3.75 mg and to a maximum of 5.0 mg to achieve a clinic BP \<140/90 mmHg.

Group Type: EXPERIMENTAL

bisoprolol

Intervention Type: DRUG

bisoprolol is administered after randomization at a dose of 2.5 mg once daily, and if needed, titrated to 3.75 mg and to a maximum of 5.0 mg to achieve a clinic BP \<140/90 mmHg.

Interventions

carvedilol

carvedilol is administered after randomization at a dose of 10 mg once daily, and if needed, titrated to 15 mg and to a maximum of 20 mg to achieve a clinic BP \<140/90 mmHg.

Intervention Type: DRUG

bisoprolol

bisoprolol is administered after randomization at a dose of 2.5 mg once daily, and if needed, titrated to 3.75 mg and to a maximum of 5.0 mg to achieve a clinic BP \<140/90 mmHg.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Never-treated hypertensive subjects, aged 20-80 years (at the time of informed consent), regardless of sex
• Clinic systolic BP/diastolic BP > 140/90 mmHg in a sitting position.

Exclusion Criteria

• Beta-blocker contraindications(asthma, COPD…)
• Heart rate less than 55 bpm
• Subjects treated with nitrates
• Grade 3 hypertension (≥180 and/or ≥110 mmHg)
• Secondary hypertension or malignant hypertension
• History of heart failure, coronary artery disease, and stroke
• Arrhythmia
• Renal dysfunction (serum creatinine ≥2.0 mg/dl)
• Hepatic dysfunction (AST and/or ALT ≥100 IU/l)
• A history of or a suspected malignant tumor within 5 years of enrollment
• Chronic inflammatory disease
• Pregnancy, childbearing potential with inadequate contraception, breast feeding
• Inability to give informed consent

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yoshio Matsui

OTHER

Sponsor Role: lead

Responsible Party

Yoshio Matsui

Sponsor investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kazuomi Kario

Role: PRINCIPAL_INVESTIGATOR

Jichi Medical University

Locations

Iwakuni City Medical Center

Yamaguchi, , Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

Yoshio Matsui

Role: CONTACT

Phone: +81-285-58-7538

Email: yoshio@jichi.ac.jp

Facility Contacts

Yoshio Matsui

Role: primary

Other Identifiers

ARTIST

Identifier Type: -

Identifier Source: org_study_id