Predictive Value of Vasodilator Challenge for Right Heart Failure (RHF) After Left Ventricular Assist Device (LVAD) Implantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Primary Endpoint
研究概览
简要总结
Prospective evaluation of the predictive value for post-LVAD right ventricular failure (RHF) of pulmonary vasodilator challenge, in addition to current laboratory, echocardiographic and haemodynamic parameters.
LVAD candidates satisfying the inclusion criteria will undergo vasodilator challenge with sodium nitroprusside (NTP) infusion following the study protocol.
Thereafter, we will evaluate all data in order to determine which variables significantly correlate with RHF onset after LVAD implantation.
详细描述
Inclusion criteria
- Age over 18 years old.
- Diagnosis of advanced heart failure with an indication for LVAD implantation.
- Mean Arterial Pressure (MAP) > 60 mmHg; Mean Pulmonary Arterial Pressure (mPAP) > 20 mmHg; Pulmonary Artery Wedge Pressure >15 mmHg.
- Vasodilator Challenge performed through NTP infusion.
Exclusion criteria
- State of pregnancy.
- Inability to perform vasodilator challenge
- Need for extracorporeal membrane oxygenator or short-term right ventricular assist devices.
- Planned right ventricular assist device implantation in the peri-procedural setting.
Right heart catheterization (RHC) RHC will be performed under optimal medical therapy within 90 days before LVAD implantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
Enrolled patients - LVAD candidates
Inclusion criteria
- Age over 18 years old.
- Diagnosis of advanced heart failure with an indication for LVAD implantation.
- Mean Arterial Pressure (MAP) > 60 mmHg; Mean Pulmonary Arterial Pressure (mPAP) > 20 mmHg; Pulmonary Artery Wedge Pressure >15 mmHg.
- Vasodilator Challenge performed through NTP infusion.
Exclusion criteria
- State of pregnancy.
- Inability to perform vasodilator challenge
- Need for extracorporeal membrane oxygenator or short-term right ventricular assist devices.
- Planned right ventricular assist device implantation in the peri-procedural setting.
干预措施: Pulmonary Vasodilators (Drug)
结局指标
主要结局
Primary Endpoint
时间窗: 18 months
Early right heart failure
次要结局
- Secondary Endpoint(24 months)
研究者
Giulio Cacioli
MD
San Camillo Hospital, Rome