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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Jichi Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Yoshio Matsui, Jichi Medical University
ClinicalTrials.gov Identifier:
NCT01243827
First received: November 18, 2010
Last updated: July 18, 2012
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: carvedilol
Drug: bisoprolol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Effect of cARvedilol Compared To bISoprolol on cenTral Pulse Pressure in Hypertension (ARTIST) Study

Resource links provided by NLM:


Further study details as provided by Jichi Medical University:

Primary Outcome Measures:
  • Change in central pulse pressure (pulse pressure amplification) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: November 2010
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Experimental: 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.
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243827

Contacts
Contact: Yoshio Matsui +81-285-58-7538 yoshio@jichi.ac.jp

Locations
Japan
Iwakuni City Medical Center Recruiting
Yamaguchi, Japan
Contact: Yoshio Matsui    +81-827-21-3211    yoshio@jichi.ac.jp   
Sponsors and Collaborators
Yoshio Matsui
Investigators
Principal Investigator: Kazuomi Kario Jichi Medical University
  More Information

No publications provided

Responsible Party: Yoshio Matsui, Sponsor investigator, Jichi Medical University
ClinicalTrials.gov Identifier: NCT01243827     History of Changes
Other Study ID Numbers: ARTIST
Study First Received: November 18, 2010
Last Updated: July 18, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Jichi Medical University:
Hypertension, carvedilol, bisoprolol, central pulse pressure, pulse pressure amplification, reflection magnitude, LV mass index, LV diastolic function

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Carvedilol
Bisoprolol
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists

ClinicalTrials.gov processed this record on August 28, 2014