NCT02352285终止4 期
Assessment of Clinical Outcome and Treatment Quality Under Adequate Use of Tolvaptan In Correction of Hyponatremia in Patients Hospitalized With Worsening Heart Failure and Hyponatremia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Average daily AUC of change from baseline in serum Na level to day 4 within the double-blind treatment period
研究概览
简要总结
The objective is to evaluate the efficacy and safety on the tolvaptan for increasing serum Na levels in patients with worsening heart failure and hyponatremia.
详细描述
This is a phase 4, multicenter, randomized, double-blind, placebo-controlled, parallel-group interventional study comparing tolvaptan (15 to 60 mg) to placebo in adult patients hospitalized (or admission to emergency room) due to worsening of heart failure and dilutional hyponatremia. All patients will be on standard therapy for heart failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients hospitalized due to heart failure with clinically significant hyponatremia (except hypovolemic) (defined as serum Na < 125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction) prior to randomization.
- •Male and female patients aged ≥ 20 years.
- •New York Heart Association (NYHA) class III/Ⅳ
- •Signs of extracellular volume expansion, defined as two or more of the following: JVD, peripheral edema, dyspnea or pulmonary congestion.
- •B-type natriuretic peptide (BNP) ≥ 150 pg/mL or N terminal (NT)-proBNP ≥ 450 pg/mL.
排除标准
- •Women who are pregnant, breast feeding, or of childbearing potential who are not using acceptable contraceptive methods
- •Patients with hyponatremia in hypovolemic states, defined as the presence of clinical and historical evidence of extracellular fluid volume depletion
- •Patients unable to sense or respond to thirst.
- •Patients who are likely to require prolonged hospitalization for reasons other than chronic heart failure (CHF)
- •Patients with recent prior treatment for hyponatremia
- •Patients with severe hyponatremia symptoms requiring immediate intervention with hypertonic saline
- •Patients with causes of neurological symptoms, which are attributable to psychological (psychoses), structural (dementia of the Alzheimer's type, post-infarct dementia) or other metabolic causes
- •Patients with acute and transient hyponatremia associated with head trauma or severe neurological injury
- •Patients with a history of hyponatremia known to be due to severe, untreated hypothyroidism/adrenal insufficiency.
- •Patients with psychogenic polydipsia.
- •Patients with systolic BP < 90 mmHg at screening.
- •Patients with a history of hypersensitivity and/or idiosyncratic reaction to benzazepine or benzazepine derivatives (such as benazepril), or tolvaptan.
- •Patients with a history of drug or medication abuse within the 3 months prior to screening, or current alcohol abuse.
- •Patients with uncontrolled diabetes mellitus
- •Patients with a current urinary tract obstruction
- •Anuric patients.
- •Patients with a serum creatinine > 3.5 mg/dL at screening.
- •Terminally ill patients or patients with a moribund condition who have little chance of short-term survival.
- •Patients whose hyponatremia is the result of any medication that cannot safely be withdrawn, such as anti-convulsants and anti psychotics
- •Patients receiving desmopressin within 2 days of screening.
- •Patients who have participated in another investigational drug trial within the past 30 days.
- •Any patient who, in the opinion of the investigator, would not be able to comply with the study drug administration or study procedures, or whose overall medical condition would prohibit their participation in the study.
- •Patients treated and/or to be treated with strong cytochrome P450 (CYP) 3A inhibitors
- •Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose- galactose malabsorption.
- •Patients with a AST or ALT > ULN 2.5 or total bilirubin > 2mg/dL
研究组 & 干预措施
Tolvaptan
Experimental
Tovaptan tablet 15mg, 30mg, 60mg, once a day, oral
干预措施: Tolvaptan (Drug)
placebo
Placebo Comparator
placebo tablet 15mg, 30mg, 60mg, once a day, oral
干预措施: Placebo (Drug)
结局指标
主要结局
Average daily AUC of change from baseline in serum Na level to day 4 within the double-blind treatment period
时间窗: from baseline to day 4
次要结局
- Average amount of furosemide used during hospitalization.(from day 1 to discharge date (up to subject condition day 2 ~ day 30))
- Average amount of furosemide used during out-patient period.(from baseline to day 30 and day 60)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
不适用
Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in SIADHAntidiuretic Hormone, Inappropriate SecretionNCT04790175Otsuka Pharmaceutical Co., Ltd.300
已完成
4 期
Tolvaptan in Hyponatremic Cancer PatientsAdvanced CancersNCT01199198M.D. Anderson Cancer Center52
Unknown
4 期
Tolvaptan for Hyponatremia in Cirrhotic Patients With AscitesAscitesHyponatremiaNCT01716611Konkuk University Medical Center105
已完成
3 期
A Multicenter Trial to Investigate the Efficacy and Safety of Tolvaptan in Patients With Hyponatremia in SIADHSyndrome of Inappropriate Antidiuretic Hormone SecretionNCT03048747Otsuka Pharmaceutical Co., Ltd.16
已完成
3 期
THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient EvaluationHyponatremiaNCT00578695CardioKine Inc.652