NCT03553303Unknown4 期
Pharmacodynamic Effects of Sacubitril/Valsartan on Natriuretic Peptides, Angiotensin and Neprilysin. A Ringerike Heart Failure Cohort Phase IV Study of Angiotensin Receptor Neprilysin Inhibiton
Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年10月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Neurohormonal plasma concentration
研究概览
简要总结
The study measure multiple neurohormones in patients with heart failure being treated with Sacubitril/Valsartan in increasing doses over an 8 week period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must give written informed consent before any study assessment is performed.
- •Ambulatory ≥ 18 years of age, male or female, treated at Ringerike Hospital.
- •Patients with symptomatic chronic heart failure and reduced ejection fraction (≤ 40%).
- •Patients on optimized medical treatment for heart failure. -
排除标准
- •Patients not able to comply in the study.
- •Patients having contraindication for treatment with Entresto;
- •Hypersensitivity to the active substances or to any of the excipients listed in section
- •Hyperkalemia: > 5.4 mmol/L
- •Known history of angioedema related to previous ACE inhibitor or ARB therapy.
- •Hereditary or idiopathic angioedema.
- •Concomitant use with Aliskiren-containing medicinal products in patients with diabetes mellitus or in patients with renal impairment (eGFR <60 ml/min/1.73m2)
- •End-stage renal disease (<15 mL/min per 1.73m2 or treatment by dialysis).
- •Severe hepatic impairment, biliary cirrhosis and cholestasis (Child-Pugh C classification).
- •Pregnancy Breast-feeding-
研究组 & 干预措施
Intervention
Experimental
Increasing doses of Sacubitril/Valsartan
干预措施: Sacubitril / Valsartan Oral Tablet (Drug)
结局指标
主要结局
Neurohormonal plasma concentration
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
Christian Hall
Professor
Oslo University Hospital
研究点 (1)
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