NL-OMON41092已完成2 期
A single center, randomized, open-label, cross-over exploratory study to evaluate the pharmacodynamic and pharmacokinetic response to a subcutaneous administration or oral administration of furosemide in subjects presenting with chronic fluid overload - Furosemide Pharmacodynamics after SC or Oral Administration (scFUROPHARM)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Written informed consent must be obtained before any assessment is performed;Male and female subjects >=18 years of age, with body weight < 120 kg and body mass index (BMI) < 30 kg/m2;Participant must have been on oral furosemide 40 mg qd or bid for a period 90 days;History of chronic heart failure with presence of moderate symptoms of decompensation. DHF is defined as presence of signs and symptoms of heart failure, like dyspnea at rest or minimal exertion, pulmonary congestion and/or peripheral edema at the time of presentation in combination with elevated levels on natriuretic peptides (NT-proBNP < 300 pg/mL);In the opinion of the investigator, able to participate in the study
排除标准
- •Contraindication to furosemide ;Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant;Systolic BP (SBP) < 90 mm Hg ;Temperature > 38°C (oral or equivalent) or sepsis or active infection requiring i.v. anti-microbial treatment;Serum sodium < 130 mEq/L and Serum potassium < 3.0 mEq/L;Current or planned (throughout the completion of study drug infusion) treatment with any i.v. therapies, including inotropic agents, vasopressors, levosimendan, nesiritide or analogues; or mechanical support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device);History of gastric or intestinal surgery that may affect absorption of oral medication;Diagnosed with diabetes mellitus requiring pharmacotherapy;Presence or need for urinary catheterization ;Current or planned ultrafiltration, hemofiltration, or dialysis;Impaired renal function defined as an estimated glomerular filtration rate (eGFR) on admission < 15mL/min/1.73 m2, calculated using the simplified Modification of Diet in Renal Disease (sMDRD) equation;Administration of intravenous radiographic contrast agent within 72 hours prior to screening or acute contrast-induced nephropathy at the time of screening;Major surgery within 30 days prior to screening;Administration of an investigational drug or implantation of investigational device, or participation in another trial, within 30 days before screening;Inability to follow instructions or comply with procedures;Any surgical or medical condition which in the opinion of the investigator may interfere with participation in the study or which may affect the outcome of the study
研究者
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