TRK820 IN PATIENTS WITH HYPONATREMIA COINCIDENT WITH CONGESTIVE HEART FAILURE

TRK820 在伴有充血性心力衰竭的低钠血症患者中的应用

• 批准号: 6297154
• 负责人: JOHN M NICKLAS
• 金额: $ 0.02万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6297154
• 关键词: body fluid balance therapy; clinical research; congestive heart failure; drug screening /evaluation; heart disorder chemotherapy; hemodynamics; human subject; human therapy evaluation; hyponatremia; intravenous administration; morphinans; placebos; urinalysis

TRK-820 is a novel 4,5 epoxy-morphinan derivative which was designed and intended for use as an analgesic. Early clinical trials using healthy volunteers demonstrated an unexpected aquaretic effect. Since then, the development of TRK-820 has been extended to include a consideration of the utility of the drug in the treatment of hyponatremia associated with fluid overload. The primary objectives of this research are to evaluate the effectiveness and safety of TRK-820 in patients with hyponatremia coincident with New York Heart Association Class III or IV heart failure. Subjects will be administered an intravenous dose of TRK-820 or placebo once each morning for 5 days. Blood sampling, urine collections, and hemodynamic measurements will be performed throughout each study day.

TRK-820是一种新型的4,5环氧 - 多翼衍生物，旨在用作镇痛药。 使用健康志愿者的早期临床试验表现出意想不到的水样作用。 从那时起，TRK-820的发展已扩展，包括考虑该药物在治疗与液体超负荷相关的低钠血症方面的效用。 这项研究的主要目标是评估TRK-820与纽约心脏协会III或IV级心力衰竭一致的低钠血症患者的有效性和安全性。受试者每天早晨一次服用静脉注射剂量的TRK-820或安慰剂5天。 在整个研究日，将进行血液采样，尿液收集和血液动力学测量。