Rationale and design of MinerAlocorticoid Receptor antagonist Tolerability Study-Heart Failure (ARTS-HF): a randomized study of finerenone vs. eplerenone in patients who have worsening chronic heart failure with diabetes and/or chronic kidney disease
Rationale and design of MinerAlocorticoid Receptor antagonist Tolerability Study-Heart Failure (ARTS-HF): a randomized study of finerenone vs. eplerenone in patients who have worsening chronic heart failure with diabetes and/or chronic kidney disease
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DOI：
10.1002/ejhf.218
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发表时间：
2015-02-01
影响因子：
18.2
通讯作者：
Filippatos, Gerasimos
中科院分区：
文献类型：
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作者：
Pitt, Bertram;Anker, Stefan D.;Filippatos, Gerasimos
目的探讨新型非甾体类盐皮质激素受体拮抗剂非那利酮治疗慢性心力衰竭恶化、左室射血分数（HFrEF）降低、高钾血症和肾功能不全恶化高危患者的安全性和潜在疗效。（ARTS-HF; NCT 01807221）是一项多中心、随机化、双盲、活性药物对照、6个平行组、2b期剂量探索研究。总共有1060例HFrEF合并2型糖尿病和/或慢性肾脏疾病（CKD）患者将在因慢性HF恶化而急诊入院的7天内随机接受非那利酮（2.5- 20.0 mg每日一次范围内的5种剂量之一）或依普利酮（25 mg每2天一次至50 mg每日一次，持续90天）。主要目的是研究不同口服剂量的非那利酮与依普利酮相比的安全性和潜在疗效（测量为第902天血浆N末端B型利钠肽原[NT-proBNP]相对于基线降低超过30%的个体百分比）。其他目的是评估非那利酮对复合临床终点的影响（任何原因导致的死亡、心血管住院或慢性HF恶化的急诊），结论ARTS-HF是第一个2b期临床试验，研究非那利酮对高血压患者血浆NT-proBNP的影响。在急诊科就诊的慢性HF恶化伴2型糖尿病和/或CKD患者的风险人群。
AimsTo investigate the safety and potential efficacy of the novel non-steroidal mineralocorticoid receptor antagonist finerenone in patients with worsening chronic heart failure and reduced left ventricular ejection fraction (HFrEF) and at high risk of hyperkalaemia and worsening renal dysfunction.Methods and resultsThe MinerAlocorticoid Receptor antagonist Tolerability Study-Heart Failure (ARTS-HF; NCT01807221) is a multicentre, randomized, double-blind, active-comparator-controlled, six-parallel-group, phase 2b dose-finding study. In total, 1060 patients with HFrEF and concomitant type 2 diabetes mellitus and/or chronic kidney disease (CKD) will be randomized within 7days of emergency presentation to hospital for worsening chronic HF to receive finerenone (one of five doses in the range 2.5-20.0mg once daily) or eplerenone (25mg every second day to 50mg once daily for 90days). The primary objective is to investigate the safety and potential efficacy (measured as the percentage of individuals with a decrease in plasma N-terminal pro-B-type natriuretic peptide [NT-proBNP] of more than 30% relative to baseline at day 902) of different oral doses of finerenone compared with eplerenone. Other objectives are to assess the effects of finerenone on a composite clinical endpoint (death from any cause, cardiovascular hospitalizations, or emergency presentations for worsening chronic HF), and on changes in health-related quality of life from baseline.ConclusionsARTS-HF is the first phase 2b clinical trial to investigate the effects of finerenone on plasma NT-proBNP in a high-risk population of patients who have worsening chronic HF with type 2 diabetes mellitus and/or CKD presenting at the emergency department.