NCT00924014Unknown不适用
Comparative Effects of Conivaptan and Loop Diuretics on Plasma Neurohormones and Systemic and Renal Hemodynamics in Subjects With Chronic Congestive Heart Failure
Hennepin County Medical Center, Minneapolis1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2009年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- renal hemodynamics renal blood flow and glomerular filtration rate
研究概览
简要总结
The purpose of the study is to compare the effects of conivaptan and diuretics on renal blood flow and neurohormones.
详细描述
- To define the hemodynamic, neurohormonal and renal responses to intravenous conivaptan in patients with chronic stable heart failure (HF), and compare these responses to those after intravenous furosemide.
- To define the hemodynamic, neurohormonal and renal responses to the combination of the two drugs (conivaptan and furosemide).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of chronic congestive heart failure of any etiology
- •Be between 18-80 years of age
- •Able to provide consent
- •Have a documented left ventricular ejection fraction within the last year of < 40%
- •On a stable dose (no changes within 2 weeks) of 40 mg or greater daily dose of furosemide or its equivalent
- •On standard HF therapy medications (ACEI or ARB and beta-blocker unless contraindicated)
- •Have an estimated glomerular filtration rate (GFR) of 30 ml/minute or greater (based on the Cockcroft Gault calculation)
- •Have a hemoglobin of > 10 grams/dl
- •Have a negative urine pregnancy for women of childbearing years only
排除标准
- •Acute coronary syndrome within 1 month
- •Systolic blood pressure less than or equal to 90 mmHg at time of enrollment
- •Poor peripheral venous access
- •Severe concomitant disease which deemed by the investigator would render them unsuitable for this trial
- •Allergy or contraindication to the use of iothalamate, PAH - Specifically any allergies to iodine or iodine containing products, history of asthma and hay fever which deemed by the investigator would render them unsuitable for this trial
研究组 & 干预措施
Conivaptan
Active Comparator
Conivaptan will be given via IV bolus
干预措施: Conivaptan (Drug)
Furosemide
Active Comparator
Furosemide will be given via IV bolus
干预措施: Furosemide (Drug)
conivaptan and furosemide
Active Comparator
on day 3 subjects will receive both study drugs
干预措施: Conivaptan and furosemide (Drug)
结局指标
主要结局
renal hemodynamics renal blood flow and glomerular filtration rate
时间窗: measured on days 1, 2, 3
次要结局
- measure plasma neurohormone levels(predose, 1 hour and 4 hours post dose measured on day 1, 2, 3)
研究者
研究点 (1)
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