Abstract
BackgroundHyperuricemia 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.MethodsThe 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.ConclusionsThe Excited-UA study would provide novel evidence for the clinical relevancy of xanthine oxidoreductase inhibitor treatment in patients with chronic heart failure and hyperuricemia.
Highlights
Hyperuricemia has a close relationship with cardiovascular diseases and is an independent risk factor for these diseases [1, 2]
We focused on serum N-terminal pro-brain natriuretic peptide (NT-proBNP) level, echocardiographybased cardiac function, vascular endothelial function, renal function, inflammation, and oxidative stress
Sakai et al [20] demonstrated that hyperuricemia is a prognostic predictor independent of plasma BNP level in patients with chronic heart failure and that high level of the plasma uric acid was in part derived from secretion from the failing heart
Summary
Hyperuricemia has a close relationship with cardiovascular diseases and is an independent risk factor for these diseases [1, 2]. Uricemic control would be an important target to treat in patients with chronic heart failure and hyperuricemia. It is still controversial whether xanthine oxidase inhibition has benefits in these patients. It is suggested that topiroxostat ameliorates impaired vascular endothelial function beyond the uric acid lowering action [7]. These pharmacological actions of topiroxostat lead us to the hypothesis that this drug could have superior effects to allopurinol for patients with chronic heart failure and hyperuricemia. We focused on serum N-terminal pro-brain natriuretic peptide (NT-proBNP) level, echocardiographybased cardiac function, vascular endothelial function, renal function, inflammation, and oxidative stress
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