The effects of xanthine oxidase inhibitor in patients with chronic heart failure complicated with hyperuricemia

a prospective randomized controlled clinical trial of topiroxostat vs allopurinol—study protocol

For Excited UA study Investigators

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Background: Hyperuricemia has a close relationship with cardiovascular diseases including heart failure. However, it is controversial whether xanthine oxidase inhibition has benefits for patients with chronic heart failure. We designed the Effect of Xanthine Oxidase Inhibitor in Chronic Heart Failure Patients Complicated with Hyperuricemia study (Excited-UA study) to compare the beneficial effects between a novel xanthine oxidoreductase inhibitor, topiroxostat, and a conventional agent, allopurinol, in patients with chronic heart failure and hyperuricemia. We focus on serum N-terminal pro-brain natriuretic peptide (NT-proBNP) level, echocardiography-based cardiac function, vascular endothelial function, renal function, inflammation, and oxidative stress. Methods: The excited-UA is a prospective, randomized, open-label, blinded-endpoint clinical trial designed to prove our hypothesis that topiroxostat is more effective than allopurinol in patients with chronic heart failure and hyperuricemia. A total of 140 patients with chronic heart failure and hyperuricemia (plasma brain natriuretic peptide level ≥ 40 pg/mL and serum uric acid level ≥ 7.0 mg/dL) are randomly assigned (ratio 1:1) into either the topiroxostat group (40–160 mg/day) or allopurinol group (100–300 mg/day), to achieve the target uric acid level of 6.0 mg/dL. According to the protocol, all patients are followed up annually for 24 weeks. The primary endpoint is percent change in serum NT-proBNP level at 24 weeks from baseline. Conclusions: The Excited-UA study would provide novel evidence for the clinical relevancy of xanthine oxidoreductase inhibitor treatment in patients with chronic heart failure and hyperuricemia.

Original languageEnglish
Pages (from-to)1379-1386
Number of pages8
JournalClinical and experimental nephrology
Volume22
Issue number6
DOIs
Publication statusPublished - 2018 Dec 1
Externally publishedYes

Fingerprint

Hyperuricemia
Xanthine Oxidase
Randomized Controlled Trials
Heart Failure
Allopurinol
Brain Natriuretic Peptide
Xanthine Dehydrogenase
Uric Acid
Serum
FYX-051
Blood Vessels
Echocardiography
Oxidative Stress
Cardiovascular Diseases
Clinical Trials
Inflammation
Kidney

Keywords

  • Allopurinol
  • Chronic heart failure
  • Hyperuricemia
  • N-terminal pro-brain natriuretic peptide (NT-proBNP)
  • Topiroxostat
  • Xanthine oxidase inhibitor

ASJC Scopus subject areas

  • Physiology
  • Nephrology
  • Physiology (medical)

Cite this

@article{e9696843fe97483ea847160152eb9228,
title = "The effects of xanthine oxidase inhibitor in patients with chronic heart failure complicated with hyperuricemia: a prospective randomized controlled clinical trial of topiroxostat vs allopurinol—study protocol",
abstract = "Background: Hyperuricemia has a close relationship with cardiovascular diseases including heart failure. However, it is controversial whether xanthine oxidase inhibition has benefits for patients with chronic heart failure. We designed the Effect of Xanthine Oxidase Inhibitor in Chronic Heart Failure Patients Complicated with Hyperuricemia study (Excited-UA study) to compare the beneficial effects between a novel xanthine oxidoreductase inhibitor, topiroxostat, and a conventional agent, allopurinol, in patients with chronic heart failure and hyperuricemia. We focus on serum N-terminal pro-brain natriuretic peptide (NT-proBNP) level, echocardiography-based cardiac function, vascular endothelial function, renal function, inflammation, and oxidative stress. Methods: The excited-UA is a prospective, randomized, open-label, blinded-endpoint clinical trial designed to prove our hypothesis that topiroxostat is more effective than allopurinol in patients with chronic heart failure and hyperuricemia. A total of 140 patients with chronic heart failure and hyperuricemia (plasma brain natriuretic peptide level ≥ 40 pg/mL and serum uric acid level ≥ 7.0 mg/dL) are randomly assigned (ratio 1:1) into either the topiroxostat group (40–160 mg/day) or allopurinol group (100–300 mg/day), to achieve the target uric acid level of 6.0 mg/dL. According to the protocol, all patients are followed up annually for 24 weeks. The primary endpoint is percent change in serum NT-proBNP level at 24 weeks from baseline. Conclusions: The Excited-UA study would provide novel evidence for the clinical relevancy of xanthine oxidoreductase inhibitor treatment in patients with chronic heart failure and hyperuricemia.",
keywords = "Allopurinol, Chronic heart failure, Hyperuricemia, N-terminal pro-brain natriuretic peptide (NT-proBNP), Topiroxostat, Xanthine oxidase inhibitor",
author = "{For Excited UA study Investigators} and Masashi Sakuma and Shigeru Toyoda and Takuo Arikawa and Yota Koyabu and Toru Kato and Taichi Adachi and Hideaki Suwa and Narita, {Jun ichi} and Koetsu Anraku and Kimihiko Ishimura and Fumitake Yamauchi and Yasunori Sato and Teruo Inoue",
year = "2018",
month = "12",
day = "1",
doi = "10.1007/s10157-018-1599-6",
language = "English",
volume = "22",
pages = "1379--1386",
journal = "Clinical and Experimental Nephrology",
issn = "1342-1751",
publisher = "Springer Japan",
number = "6",

}

TY - JOUR

T1 - The effects of xanthine oxidase inhibitor in patients with chronic heart failure complicated with hyperuricemia

T2 - a prospective randomized controlled clinical trial of topiroxostat vs allopurinol—study protocol

AU - For Excited UA study Investigators

AU - Sakuma, Masashi

AU - Toyoda, Shigeru

AU - Arikawa, Takuo

AU - Koyabu, Yota

AU - Kato, Toru

AU - Adachi, Taichi

AU - Suwa, Hideaki

AU - Narita, Jun ichi

AU - Anraku, Koetsu

AU - Ishimura, Kimihiko

AU - Yamauchi, Fumitake

AU - Sato, Yasunori

AU - Inoue, Teruo

PY - 2018/12/1

Y1 - 2018/12/1

N2 - Background: Hyperuricemia has a close relationship with cardiovascular diseases including heart failure. However, it is controversial whether xanthine oxidase inhibition has benefits for patients with chronic heart failure. We designed the Effect of Xanthine Oxidase Inhibitor in Chronic Heart Failure Patients Complicated with Hyperuricemia study (Excited-UA study) to compare the beneficial effects between a novel xanthine oxidoreductase inhibitor, topiroxostat, and a conventional agent, allopurinol, in patients with chronic heart failure and hyperuricemia. We focus on serum N-terminal pro-brain natriuretic peptide (NT-proBNP) level, echocardiography-based cardiac function, vascular endothelial function, renal function, inflammation, and oxidative stress. Methods: The excited-UA is a prospective, randomized, open-label, blinded-endpoint clinical trial designed to prove our hypothesis that topiroxostat is more effective than allopurinol in patients with chronic heart failure and hyperuricemia. A total of 140 patients with chronic heart failure and hyperuricemia (plasma brain natriuretic peptide level ≥ 40 pg/mL and serum uric acid level ≥ 7.0 mg/dL) are randomly assigned (ratio 1:1) into either the topiroxostat group (40–160 mg/day) or allopurinol group (100–300 mg/day), to achieve the target uric acid level of 6.0 mg/dL. According to the protocol, all patients are followed up annually for 24 weeks. The primary endpoint is percent change in serum NT-proBNP level at 24 weeks from baseline. Conclusions: The Excited-UA study would provide novel evidence for the clinical relevancy of xanthine oxidoreductase inhibitor treatment in patients with chronic heart failure and hyperuricemia.

AB - Background: Hyperuricemia has a close relationship with cardiovascular diseases including heart failure. However, it is controversial whether xanthine oxidase inhibition has benefits for patients with chronic heart failure. We designed the Effect of Xanthine Oxidase Inhibitor in Chronic Heart Failure Patients Complicated with Hyperuricemia study (Excited-UA study) to compare the beneficial effects between a novel xanthine oxidoreductase inhibitor, topiroxostat, and a conventional agent, allopurinol, in patients with chronic heart failure and hyperuricemia. We focus on serum N-terminal pro-brain natriuretic peptide (NT-proBNP) level, echocardiography-based cardiac function, vascular endothelial function, renal function, inflammation, and oxidative stress. Methods: The excited-UA is a prospective, randomized, open-label, blinded-endpoint clinical trial designed to prove our hypothesis that topiroxostat is more effective than allopurinol in patients with chronic heart failure and hyperuricemia. A total of 140 patients with chronic heart failure and hyperuricemia (plasma brain natriuretic peptide level ≥ 40 pg/mL and serum uric acid level ≥ 7.0 mg/dL) are randomly assigned (ratio 1:1) into either the topiroxostat group (40–160 mg/day) or allopurinol group (100–300 mg/day), to achieve the target uric acid level of 6.0 mg/dL. According to the protocol, all patients are followed up annually for 24 weeks. The primary endpoint is percent change in serum NT-proBNP level at 24 weeks from baseline. Conclusions: The Excited-UA study would provide novel evidence for the clinical relevancy of xanthine oxidoreductase inhibitor treatment in patients with chronic heart failure and hyperuricemia.

KW - Allopurinol

KW - Chronic heart failure

KW - Hyperuricemia

KW - N-terminal pro-brain natriuretic peptide (NT-proBNP)

KW - Topiroxostat

KW - Xanthine oxidase inhibitor

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U2 - 10.1007/s10157-018-1599-6

DO - 10.1007/s10157-018-1599-6

M3 - Article

VL - 22

SP - 1379

EP - 1386

JO - Clinical and Experimental Nephrology

JF - Clinical and Experimental Nephrology

SN - 1342-1751

IS - 6

ER -