NCT03217331已完成1 期
CRD-102 for Right Heart Failure in Patients With Left Ventricular Assist Devices
Cardiora Pty. Ltd.1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2018年3月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Safety: Subject incidence of adverse events
研究概览
简要总结
This is a Phase 1b/IIa, single centre, non-randomised open-label uncontrolled study to assess safety, effect and PK of oral CRD-102 in patients with RHF associated with the presence of an LVAD.
详细描述
The study will be conducted over a 40 day time period inclusive of screening and follow up time periods. Eligible subjects will receive oral CRD-102 for 14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are enrolled only if they met the following criteria.
- •Males and females aged 18-85 years inclusive
- •Have received a LVAD (HeartWare HVAD, HeartMate II) at least 30 days prior to screening.
- •Stable LVAD patients with evidence of ongoing right heart failure as evidenced by raised right atrial pressure indicated by JVP >6cm OR measured right atrial pressure ≥12mmHg within the 3 months prior to or at Baseline OR dilated IVC on echocardiography PLUS all of the following;
- •ongoing diuretic therapy;
- •echocardiography in the 3 months prior to or at Baseline showing at least mild impairment in overall RV systolic function by visual assessment together with a TAPSE < 14mm.
- •Able to give written informed consent and agree to adhere to all protocol requirements.
- •All patients will be required to have an implanted cardiaoverter defibrillator. (ICD)
排除标准
- •Hemodynamically unstable patients.
- •Hypotension (MAP<60 or systolic BP <90 mmHg) at Screening or Baseline
- •Hypertension (MAP>95 or systolic BP >130 mmHg) at Screening or Baseline
- •Ventricular tachycardia or ventricular fibrillation in the past 30 days or poorly controlled atrial fibrillation (ventricular rate >120 bpm)
- •Concurrent participation in another investigational device study or prior participation in which a device was implanted and remains in place
- •Receipt of any investigational research agent within 30 days or 5 half-lives (whichever is longer) prior to Baseline.
- •Current treatment with intravenous inotropes or levosimendan, or treatment within the 2 weeks prior to Screening
- •Significant renal (eGFR<25 ml/min/1.73 sq m) or hepatic (bilirubin >3mg/dL) impairment or anemia (Hb <90g/dL) at Screening or Baseline.
- •Expected heart transplantation within the study period.
- •History of allergic reaction to milrinone or any excipients in the study drug.
研究组 & 干预措施
CRD-102 Treatment
Experimental
CRD102 Treatment
干预措施: CRD-102 (Drug)
结局指标
主要结局
Safety: Subject incidence of adverse events
时间窗: 40 days
Number of adverse events as a measure of safety and tolerability.
次要结局
未报告次要终点
研究者
研究点 (1)
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