Phase 3 Study of Alprostadil Continuous Intravenous Infusion to Maintain Clinical Stability in Severe Heart Failure Patients
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Time to all-cause mortality (defined as death, heart transplant, LVAD placement, mechanical circulatory support, or HF event(* hospitalization for HF or unplanned intravenous therapy for HF, ie diurectics, inotropes, vassopressors, or vasodilators.)
研究概览
简要总结
This is a global multicenter, doubleblind, placebo-controlled, randomized, parallel-group study that compares ALP-1 given in a continuous infusion ( compared to placebo), 250mcg/day on majore outcomes up to 6 months after randomization in participants with advanced HF with reduced ejection fraction(HFrEF).
详细描述
We anticipate needing to screen ca. 600 patients in order to ransomize our target sample size of 400 participants. Participants will be randomozed 1:1to receive either alprostadil or placebo. Based on prior data, we expect the 6-month event rate to be 64% in the control group and 47% in the intervention group.
The planned duration of following-up for each patient is 6 months on the randomized trial intervention and a final follow-up visit will be performed 30 days after stopping the trial intervention. Eligible patients will be randomzied via a centralized IXRS to eith alprstadil or placebo. The planned study dusration is approximately 3-4 years from first randomized patient to last patient.
When a participant is deemed eligible to participate in the trial, a central line which will be used for infusion of double-blind treatment will be inserted, if not already in place. Continue infusion delivery system will be operated by a pump.
Infusion of trial intervention will be initiated while the participant is in the hospital of infusion centre and the participant is to remain under observation for at least 8 hours for monitoring of vital signs and adverse event(AEs).
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)
盲法说明
The party or parties involved in the study trials who are prevented from having knowledge of the interventions assigned to individual participants
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
trial arm
6 months central continuous infusion with Alp_1 by infusion pump.
干预措施: Alprostadil (Drug)
Placebo arm
6 months central infusion with NS by infusion pump with exact infusion rat as trial arm.
干预措施: Alprostadil (Drug)
结局指标
主要结局
Time to all-cause mortality (defined as death, heart transplant, LVAD placement, mechanical circulatory support, or HF event(* hospitalization for HF or unplanned intravenous therapy for HF, ie diurectics, inotropes, vassopressors, or vasodilators.)
时间窗: 6 months infusion
To access the effect of continue 6-months ALP-1infusion at a fixed dose of at 500mcg/48 hr. in patinets with advanced heart failure with reduced ejection fraction(HrEF) compare to placebo.
次要结局
- Secondary Efficacy and Safety Endpoints(6 months)