A Proof of Concept Study to Determine the Efficacy of Entresto™ in HFpEF Based on Circulating Neprilysin Levels: The Circulating NEP and NEP Inhibition (CNEPi) Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Plasma N-terminal Proatrial Natriuretic Peptide (NT proANP)
研究概览
简要总结
To determine biomarker responses to Entresto™in patients with Heart Failure with preserved Ejection Fraction (HFpEF) and who have high or low serum neprilysin (NEP) levels.
详细描述
This is a proof of concept single arm study in which 40 subjects with HFpEF will be assigned to Entresto™ 49/51 mg (sacubitril/valsartan) twice-daily for a total duration of up to 5 weeks of treatment. Blood will be drawn prior to and at completion of treatment. The primary endpoint measured is change in biomarkers with Entresto™ administration that reflect NEP activity and myocardial stress (NT pro-ANP, -BNP, -CNP) and drug action (cGMP). This endpoint has been well validated as a measure of Entresto™ drug response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Low Serum Neprilysin (sNEP) levels
Subjects with baseline sNEP levels less than or equal to 0.9 ng/ml
干预措施: Entresto™ 49Mg-51 mg tablet (Drug)
High Serum Neprilysin (sNEP) levels
Subjects with baseline sNEP greater than or equal to 0.9 ng/ml
干预措施: Entresto™ 49Mg-51 mg tablet (Drug)
结局指标
主要结局
Change in Plasma N-terminal Proatrial Natriuretic Peptide (NT proANP)
时间窗: baseline, 5 weeks
Change in plasma NT pro-ANP value levels as measured in pg/mL. NT-pro ANP means N-terminal polypeptide of ANP (atrial natriuretic peptide) precursor. Natriuretic peptides are substances made by the heart. Elevated levels can mean the heart isn't pumping as much blood the body needs.
Change in Plasma N-terminal Brain Natriuretic Peptide (BNP)
时间窗: baseline, 5 weeks
Change in plasma BNP biomarker value levels as measured in pg/mL. Brain natriuretic peptide is a hormone secreted by cardiomyocytes in the heart ventricles in response to stretching caused by increased ventricular blood volume. Elevated levels can mean the heart isn't pumping as much blood the body needs.
Change in Plasma Cyclic Guanine Monophosphate (cGMP)
时间窗: baseline, 5 weeks
Change in Plasma cGMP biomarker value levels as measured in nmol/L. Cyclic guanosine monophosphate is a cyclic nucleotide derived from guanosine triphosphate. cGMP acts as a second messenger to tissue and cellular responses.
Change in Plasma N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)
时间窗: baseline, 5 weeks
Change in plasma NT pro-ANP value levels as measured in pg/mL. Natriuretic peptides are substances made by the heart. Two main types of these substances are brain natriuretic peptide (BNP) and N-terminal pro b-type natriuretic peptide (NT-proBNP). Elevated levels can mean the heart isn't pumping as much blood the body needs.
次要结局
未报告次要终点
研究者
Naveen L. Pereira
Professor of Medicine
Mayo Clinic