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

NCT01243827 | Unknown Phase 4 DMC

• 1 other identifier: ARTIST
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in central pulse pressure (pulse pressure amplification)

  12 months

Secondary Outcomes (1)

• 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

Study Arms (2)

carvedilol

EXPERIMENTAL

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

bisoprolol

EXPERIMENTAL

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

Interventions

carvedilol 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.

carvedilol

bisoprolol 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.

bisoprolol

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yoshio Matsui: lead

Study Sites (1)

Iwakuni City Medical Center

Yamaguchi, Japan

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Carvedilol; Bisoprolol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Phenoxypropanolamines

Study Officials

• Kazuomi Kario

  Jichi Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoshio Matsui

CONTACT

+81-285-58-7538; yoshio@jichi.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor investigator

Study Record Dates

• First Submitted: November 18, 2010
• First Posted: November 19, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: April 1, 2013
• Last Updated: July 19, 2012

Record last verified: 2010-11

Locations

JP (1)