Comparison of Effect of cARvedilol Compared To bISoprolol on cenTral Pulse Pressure in Hypertension (ARTIST) Study
Information source: Jichi Medical University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: carvedilol (Drug); bisoprolol (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Yoshio Matsui Official(s) and/or principal investigator(s): Kazuomi Kario, Principal Investigator, Affiliation: Jichi Medical University
Overall contact: Yoshio Matsui, Phone: +81-285-58-7538, Email: yoshio@jichi.ac.jp
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.
Clinical Details
Official title: Comparison of Effect of cARvedilol Compared To bISoprolol on cenTral Pulse Pressure in Hypertension (ARTIST) Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in central pulse pressure (pulse pressure amplification)
Secondary outcome: 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
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
Minimum age: 20 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Yoshio Matsui, Phone: +81-285-58-7538, Email: yoshio@jichi.ac.jp
Iwakuni City Medical Center, Yamaguchi, Japan; Recruiting Yoshio Matsui, Phone: +81-827-21-3211, Email: yoshio@jichi.ac.jp
Additional Information
Starting date: November 2010
Last updated: July 18, 2012
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