A Randomized, Double-Blind, Placebo-Controlled, Adaptive, Ascending Dose-Titration Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Invasive Hemodynamics of TRV120027 in Patients With Stable Heart Failure
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Trevena Inc.
- 入组人数
- 33
- 试验地点
- 8
- 主要终点
- Pulmonary Capillary Wedge Pressure (PCWP)
研究概览
简要总结
In this study, TRV120027 (or a placebo) intravenous infusion will be given to people with heart failure to learn about the effects of TRV120027. The results of this study will help choose the proper range of TRV120027 doses to use in future research studies involving patients with acute decompensated 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of congestive heart failure made at least 3 months prior to screening
- •NYHA Class III or IV heart failure, ejection fraction </= 35% and , and in the opinion of the investigator, right-heart catheterization is clinically indicated.
- •Baseline mean PCWP >/= 20 mmHg
- •Systolic blood pressure at screening must be >/= 100 mmHg. Heart rate at screening must be </= 90 bpm.
排除标准
- •Any significant disease or condition that would interfere with the interpretation of safety or efficacy in this study as determined by the Investigator based on medical history, physical examination or laboratory tests.
- •Significant valve disease
- •Current signs or symptoms of acute myocardial ischemia or acute coronary syndrome (ACS) or coronary revascularization in the past 3 months.
- •Sustained or uncontrolled ventricular arrhythmia. Inclusion of patients with atrial fibrillation with a heart rate ≤ 90 bpm is permitted.
研究组 & 干预措施
TRV120027
干预措施: TRV120027 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Pulmonary Capillary Wedge Pressure (PCWP)
时间窗: Multiple time points during 14 hr infusion and during 4 hr period after end of infusion
The effect of TRV120027 on pulmonary capillary wedge pressure will be compared to baseline and to placebo at multiple measurement time points during the 14 hour infusion and for 4 hours after discontinuation of the infusion.
Safety and Tolerability
时间窗: Multiple time points during 14 hr infusion and during 4 hr period after end of infusion, and follow-up (Day 7, Day 30)
Safety and tolerability will be assessed qualitatively by evaluating adverse events, clinical laboratories, ECGs, cardiac telemetry and vital signs at multiple measurement time points during the 14 hour infusion and for 4 hours after discontinuation of the infusion. Follow-up assessments for adverse events at Day 7 and Day 30 will be conducted.
次要结局
- Pharmacokinetics of TRV120027(Multiple time points during 14 hr infusion and during 4 hr period after end of infusion)
- Additional Hemodynamics(Multiple time points during 14 hr infusion and during 4 hr period after end of infusion)
- Laboratory Evaluations(Multiple time points during 14 hr infusion and during 4 hr period after end of infusion, and follow-up (Day 7))