AiDing Diuresis wIth Tolvaptan (ADD-IT)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Length of Hospitalization Measured in Days
研究概览
简要总结
The purpose of this study is to test the use of tolvaptan (commercial name Samsca) when given in addition to intravenous (IV) diuretics early during an episode of acute heart failure. It will be compared to a high dose of IV diuretics alone or the use of metolazone in addition to IV diuretics. The investigators are looking to see if there is improvement in the symptoms and outcomes of persons with acute heart failure.
详细描述
This is a single-center, randomized trial to assess the effects of 30 mg daily of tolvaptan when given concomitantly with home dose of diuretic (Lasix equivalent) intravenously (IV) versus 5mg daily of metolazone given concomitantly with home dose of diuretic (Lasix equivalent) IV, versus 2.5 times home dose of diuretic (Lasix equivalent) IV in participants hospitalized for acutely decompensated heart failure (ADHF).
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants hospitalized for worsening acute heart failure and randomized within 36 hours of initial presentation
- •New York Heart Association (NYHA) Class III or IV on admission to the hospital with at least 1 month history of treated heart failure
- •Able to understand content of and willing to provide written informed consent
- •The participant must have signs of extracellular volume expansion, defined as two or more of the following four signs or symptoms:
- •signs of RHF (right heart failure) (jugular venous distention, pitting edema, or (≥1+), ascites and/or signs of LHF (left heart failure) (pulmonary congestion on chest x-ray, pulmonary rales)
- •Brain Natriuretic Peptide (BNP) > 450
- •serum sodium < 140 mEq/L
排除标准
- •Positive urine pregnancy test for women of child bearing potential
- •Inability to provide written informed consent
- •Cardiac surgery within 60 days prior to study randomization
- •Acute Coronary Syndrome (ACS) or percutaneous coronary intervention within 30 days prior to study randomization
- •Planned revascularization procedures, cardiac mechanical support implantation, cardiac transplantation, or other cardiac surgery within 30 days following study randomization
- •Planned electrophysiologic (EP) device implantation within 7 days following study randomization
- •Subjects who are on cardiac mechanical support
- •Co- morbid condition with an expected survival less than six months
- •History of a cerebrovascular accident within the last 30 days
- •Hemodynamically significant uncorrected primary cardiac valvular disease
- •Hypertrophic cardiomyopathy (obstructive or non-obstructive)
- •Uncorrected thyroid disease, active myocarditis or known amyloid cardiomyopathy
- •History of primary significant liver disease or acute hepatic failure, defined as 3x upper limit of normal (ULN)
- •Chronic uncontrolled diabetes mellitus with Hemoglobin A1C > 10%
- •Supine systolic arterial blood pressure < 90 mmHg
- •Serum creatinine > 3.5 mg/dL or undergoing dialysis
- •Hemoglobin < 9 g/dL
- •History of hypersensitivity and/or idiosyncratic reaction to benzazepine derivatives (such as benazepril)
- •Inability to take oral medications
- •Participation in another clinical drug or device trial where the last dose of drug was within the past 30 days or an investigational medical device is currently implanted
- •Previous exposure to tolvaptan within 7 days prior to randomization
- •Subjects with refractory, end-stage, heart failure defined as subjects who are appropriate candidates for specialized treatment strategies, such as ventricular assist devices, continuous positive IV inotropic therapy, or hospice care
- •Ultrafiltration within 7 days prior to randomization or planned.
- •Active gout
研究组 & 干预措施
Tolvaptan 30 mg and IV Lasix
Participants admitted to the hospital and diagnosed with acutely decompensated heart failure (ADHF) will receive 30 mg of tolvaptan concomitantly with their standard dose of diuretics.
干预措施: Tolvaptan 30 mg + IV Diuretics (Drug)
Metolazone 5mg and IV Lasix
Participants admitted to the hospital and diagnosed with acutely decompensated heart failure (ADHF) will receive 5mg metolazone concomitantly with their standard dose of diuretics.
干预措施: Metolazone 5 mg + IV Diuretics (Drug)
IV Lasix
Participants admitted to the hospital and diagnosed with acutely decompensated heart failure (ADHF) will receive two and a half (2.5) times their standard dose of diuretics.
干预措施: 2.5 times the Diuretics Dose (Drug)
结局指标
主要结局
Length of Hospitalization Measured in Days
时间窗: Duration of Hospitalization (Average of Five Days)
The number of days hospitalized until discharge.
次要结局
- Change in Body Weight(Baseline (hospital admission), Discharge (Average of 5 Days))
- Total Diuretic Dose(Up to Five Days)
- Change in estimated glomerular filtration rate (eGFR)(Baseline (hospital admission), Discharge (Average of 5 days))
- Number of Days Alive(Post Hospital Discharge (30 days))
- Number of Electrolyte Imbalance Related Adverse Events(Duration of Hospitalization (Average of Five Days))
- Rate of Re-Hospitalization(30 Days Post Hospitalization)
- Number of Participants Requiring Electrolyte Repletion(Duration of Hospitalization (Average of Five Days))
- Change in Sodium Level(Baseline (hospital admission), Discharge (Average of 5 days))
研究者
Divya Gupta
Assistant Professor
Emory University