A study to evaluate the Pharmacokinetics and Pharmacodynamics of tolvaptan in congestive heart failure patients with renal impairment - A study to evaluate the Pharmacokinetics and Pharmacodynamics of tolvaptan in congestive heart failure patients with renal impairment

St. Marianna University Hospital0 个研究点目标入组 18 人开始时间: 2011年12月8日最近更新: 2023年10月17日

适应症

试验速览

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•(1)history of allergy against this drug or similar compounds (2)patients who cannot feel thirsty or have difficulty to drink (3)patients who have difficulty to peroral drug administration (4)patients whose HF symptoms are remarkably unstable (5)patients who have circulation assist (6)patients who have disease, complication or symptom as follows; possibly hypovolemic *systolic blood pressure<90mmHg *hypertrophic cardiomyopathy *active myocarditis or amyloid cardiomyopathy *severe valvular cardiopathy *severe diabetes *body mass index (BMI)>35 *anuria (urine volume<100ml/day) *impairment of urinary excretion due to urinary stenosis, calculus or tumor *hepatic coma *subjects who are pregnant or possibly pregnant (7)patients who have a history as follows; *a history of sustained ventricular tachycardia or ventricular fibrillation in patients who do not have ICD *a history of cerebrovascular disease within 6 months (except for asymptomatic ischemic stroke ) *a history of acute myocardial infarction within 30 days (8)patients whose laboratory tests are as follows; *serum Na>147mEq/L *serum K>5.5mEq/L *T.B>3.0mg/dL (9)patients who are judged to be inappropriate to this study

发起方

St. Marianna University Hospital