Acute Heart Failure With High Copeptin Levels Treated With Tolvaptan Targets Increased AVP Activation for Treatment Efficacy
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 350
- 主要终点
- Dyspnea
研究概览
简要总结
Patients being hospitalized for acute heart failure and already receiving standard therapy will be randomized to receive either tolvaptan or placebo, based on the level of copeptin measured in their bloodstream. Patients with high copeptin levels will be able to participate in the trial, patients with low levels will be excluded. Patients being admitted to the observation unit for acute heart failure and already receiving standard therapy will be randomized to receive either tolvaptan or placebo without consideration of the copeptin level. The hypothesis is that patients receiving tolvaptan will have better improvement of shortness of breath than those receiving placebo, within 9 hours of drug administration.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Older than or equal to 18 years of age, with diagnosis and planned treatment for Acute Heart Failure
- •Dyspnea at rest or minimal exertion per the patient
- •Evidence of extracellular volume expansion by at least one of the following: JVD, Rales, Ascites, Edema or positive Chest X-ray defined as cardiomegaly, pulmonary vascular congestion, Kerley B-lines, pulmonary edema and/or pleural effusion.
- •Elevated BNP level >200 pg/ml, or NTproBNP > 1000pg/mL
- •Able to administer study drug within 8 hours from triage time
- •Inpatient Hospitalized Inclusion Only:
- •Co-peptin level > 27 pmol/L
排除标准
- •Unable to provide informed consent
- •Unable to have 30 day telephone follow up
- •Not expected to survive past 6 months
- •On Renal replacement therapy or creatinine >3.5
- •History of allergy or intolerance to Tolvaptan
- •Suspected Pregnancy
- •Cardiogenic Shock
- •Participation in any interventional trial in prior 30 days.
- •Receiving or planned to receive IV Inotropic therapy
- •ACS now or in the past 30 days
- •Treatment with IV infusion vasoactive drugs in the hour prior to enrollment
- •Temperature > 100.5
- •Heart Failure due to atrial fibrillation with Rapid Ventricular Response
- •SBP < 90 mmHg
研究组 & 干预措施
Standard therapy plus Tolvaptan
Patient in the interventional group will receive tolvaptan in addition to standard therapy
干预措施: Tolvaptan (Drug)
Standard therapy plus placebo
干预措施: placebo (Drug)
结局指标
主要结局
Dyspnea
时间窗: 9 hours
Dyspnea will be evaluated at 9 hours
次要结局
- Length of stay(during hospitalizaton)
- Rehospitalization(30 days)