JPRN-UMIN000023353已完成未知
An analysis on distribution of serum concentration of bisoprolol and its effect on prognosis in patients with heart failure - CVI ARO 6 study
The Cardiovascular Institute0 个研究点目标入组 128 人开始时间: 2016年7月27日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 128
研究概览
简要总结
The data of 114 HF patients under once-daily bisoprolol was analyzed. In multivariate logistic regression analysis, independent predictors of high Bis-PC (1st tertile: >= 5.38 ng/mL) were age, eGFR, and bisoprolol dose. The cumulative incidence rates of the primary endpoint were 10.5%/13.2%/26.3% in low/middle/high Bis-PC categories, respectively (log rank test, p = 0.087). Bis-PC was independently associated with the primary endpoint (hazard ratio [HR], 1.19 [per ng/mL], 95% CI 1.03-1.36).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- ot applicable 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(1) Inpatients at blood sampling of serum concentration (2) Dose of bisoprolol was changed within 1 month before blood sampling of serum concentration. (3) Bisoprolol was administered twice a day within 1 week before blood sampling of serum concentration. (4) Hyperthyroidism is diagnosed or suspected. (5) Patients who meet contraindications below: 1) Patients with advanced bradycardia (significant sinus bradycardia), atrioventricular block (II or III degree) , atrioventricular block, and/or sick sinus syndrome 2) Patients with diabetic ketoacidosis, and/or metabolic acidosis 3) Patients with cardiogenic shock 4) Patients with right-sided heart failure by pulmonary hypertension 5) Patients with heart failure requiring intravenous administration of inotropic agents and/or vasodilatory agents 6) Patients with decompensated heart failure 7) Patients with severe peripheral circulatory disturbance 8) Patients with untreated pheochromocytoma 9) Women who are pregnant or may be pregnant 10) Patients who have a history of hypersensitivity for bisoprolol (6) Patients who are judged by the researchers as inadequate for this study
研究者
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