A Phase IV, Open-Label Safety Evaluation of the Effect of DEFINITY® on Pulmonary Artery Hemodynamics in Patients With Normal and Increased Pulmonary Artery Pressure
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 8
- 主要终点
- Percent Change in Pulmonary Artery Pressure Change From 1 Minute Pre-dose to 31 - 35 Minutes Post Dose
研究概览
简要总结
The purpose of this clinical research is to learn if DEFINITY® 416 will cause any adverse effects during Right Heart Catheterization. This research was requested by the FDA.
详细描述
This Phase IV safety study will provide safety data on potential systemic and pulmonary hemodynamic effects caused by the administration of DEFINITY® in patients who are to undergo right heart cardiac catheterization for clinical reasons. Using a right heart catheter for direct measurements of pulmonary artery hemodynamics will allow accurate assessments of potential alterations of the pulmonary vasculature. This will be further investigated by the inclusion of two patient populations, one with a baseline pulmonary artery pressure < 35 mmHg, and one with elevated baseline pulmonary artery pressure. The addition of immune parameter measurements will assess a potential link between systemic and pulmonary alterations and potential immune reactions following DEFINITY® administration.
The inclusion of patients in this study is not based on a required echocardiogram with DEFINITY® administration because patients would be exposed to an unjustifiable risk of invasive right heart catheterization and are unlikely to consent to such a procedure. Therefore, patients undergoing heart catheterization for clinical reasons, or patients who are undergoing pulmonary artery hemodynamic assessments will be enrolled and receive DEFINITY® in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Appropriate candidate scheduled to undergo right heart catheterization and measurement of pulmonary artery hemodynamics for clinical reasons
- •Be male or female above the age of 18
- •Female patients who no longer have child-bearing potential
- •Women of Child-Bearing Potential(WOCBP) who:
- •are not pregnant and have been using an adequate and medically approved method of contraception
- •have a negative urine pregnancy test
- •Be able and willing to communicate effectively with study center personnel.
排除标准
- •Women who are pregnant or lactating
- •Known hypersensitivity or contraindication to or greater heart block
- •Previous heart transplant
- •Known right-to-left shunt (including atrial septal defect)
- •Severe pulmonary artery hypertension (i.e., > 75 mmHg
- •Current uncontrolled ventricular tachycardia
- •Second-degree or greater heart block
- •Any contraindications for the use of a right heart catheter
研究组 & 干预措施
Low Pulmonary Arterial Pressure
Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
干预措施: Definity (Drug)
Elevated Pulmonary Arterial Pressure
Subjects with a PAP of > or = to 35 mmHg.
干预措施: Definity (Drug)
结局指标
主要结局
Percent Change in Pulmonary Artery Pressure Change From 1 Minute Pre-dose to 31 - 35 Minutes Post Dose
时间窗: 31-35 minutes minus baseline
Percent change in pulmonary atery pressure change from immediately pre-dose to 31 - 35 minutes post dose
次要结局
- Immunology Panel- Complement 3A (C3A)(Out to 70 minutes)
- Immunology Panel- Interleuken-6(Out to 70 minutes)
- Immunology Panel- Complement 5A(C5A)(Out to 70 minutes)
- Immunology Panel- Tryptase(Out to 70 minutes)