Clinical trial NCT01243827: Comparison of Effect of cARvedilol Compared To bISoprolol on cenTral Pulse Pressure in Hypertension (ARTIST) Study
Official title: Comparison of Effect of cARvedilol Compared To bISoprolol on cenTral Pulse Pressure in Hypertension (ARTIST) Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypertension
Keywords: Hypertension, carvedilol, bisoprolol, central pulse pressure, pulse pressure amplification, reflection magnitude, LV mass index, LV diastolic function
Lead sponsor: Jichi Medical University
Sponsor class: OTHER
First posted: 2010-11-19
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in central pulse pressure (pulse pressure amplification)
timeFrame: 12 months
Secondary outcomes:
measure: 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
timeFrame: 12 months
Other outcomes:
Locations:
city: Yamaguchi
country: Japan
facility: Iwakuni City Medical Center
Study officials:
affiliation: Jichi Medical University
name: Kazuomi Kario
role: PRINCIPAL_INVESTIGATOR
References: