A Randomized Parallel Group Controlled Comparison Study of Clevidipine Versus Placebo or Standard of Care for Dyspnea and Blood Pressure Control in Acute Heart Failure (PRONTO II)
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 18
- 主要终点
- Change in dyspnea VAS score from baseline at 3 hours post-baseline
研究概览
简要总结
The purpose of this study is to evaluate dyspnea improvement and other parameters of efficacy and safety in acute heart failure (AHF) patients receiving an intravenous (IV) infusion of clevidipine in comparison to standard of care (SOC) and placebo.
详细描述
Randomization will occur in two stages. Stage 1 patients will be randomized in a double-blinded manner in a 1:1 ratio to receive either clevidipine or placebo IV infusion. Upon completion of Stage 1, Stage 2 patients will be randomized in an open-label manner in a 1:1 ratio to receive either clevidipine or standard of care (SOC) IV infusion. At the time of randomization, a patient-specific, prespecified systolic blood pressure (SBP) target range will be determined and recorded prior to study drug treatment. Up to 500 patients may be enrolled to achieve a total of 100 Stage 1 and 300 Stage 2 patients with confirmed AHF per protocol.
A Data Safety Monitoring Board will be utilized periodically throughout the study to monitor the safety of patients. Adverse events will be assessed for 7 days post-study randomization or hospital discharge, whichever occurred sooner. Serious adverse events (SAEs) were assessed for 30 days following study randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Age 18 years or older and providing
- •Presentation consistent with AHF as manifest by pulmonary congestion
- •Dyspnea score (sitting) ≥ 50 mm on a 100 mm visual analog scale
- •In Stage 1, baseline SBP ≥130 - 160 mmHg (measured immediately prior to initiation of study drug); in Stage 2, baseline SBP ≥ 130 mmHg
排除标准
- •Administration of an IV or oral antihypertensive agent within the previous 2 hours of randomization (short acting oral or sublingual nitrates are permitted)
- •Chest pain and/or electrocardiogram (ECG) with ST segment changes consistent with acute coronary syndrome
- •Known or suspected aortic dissection
- •Acute myocardial infarction (AMI) within the prior 14 days
- •Dialysis-dependent renal failure
- •Requirement for immediate endotracheal intubation
- •Suspected pregnancy or breast feeding female
- •Intolerance or allergy to calcium channel blockers
- •Allergy to soybean oil or lecithin
- •Known liver failure, cirrhosis or pancreatitis
- •Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment
结局指标
主要结局
Change in dyspnea VAS score from baseline at 3 hours post-baseline
时间窗: Immediately prior to study drug administration (baseline) to 3 hours post-baseline
次要结局
- Median time to reach target BP within the first 30 minutes(Study drug initiation through the first 30 minutes of study drug infusion)
- Percentage of patients who require rescue therapy (ie, receive any alternative IV antihypertensive drug) within the first 30 minutes(Study drug initiation through the first 30 minutes of study drug infusion)