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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01243827
• Other study ID #: ARTIST
• Status: Recruiting
• Phase: Phase 4
• First received: November 18, 2010
• Last updated: July 18, 2012
• Start date: November 2010
• Est. completion date: April 2013

Study information

• Verified date: November 2010
• Source: Jichi Medical University
• Contact: Yoshio Matsui
• Phone: +81-285-58-7538
• Email: yoshio[@]jichi.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Japan	Iwakuni City Medical Center	Yamaguchi

Sponsors (1)

Lead Sponsor	Collaborator
Yoshio Matsui

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in central pulse pressure (pulse pressure amplification)		12 months	Yes
Secondary	Change in LV mass index Changes in LV diastolic functions (E/Em, left atrium volume) Changes in urinary albumin excretion, B-type natriuretic peptide (BNP), HOMA-IR, and oxidative stress (urinary 8-isoprostane). Change in ambulatory BP		12 months	Yes