CTRI/2024/04/065318尚未招募2 期
Sildenafil Monotherapy versus Bosentan as an Add-on for persistent pulmonary hypertension of newborn- an exploratory study - SiMBA
All India Institute of Medical Sciences AIIMS Rishikesh0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Any intubated neonate more than or equal to 34 w gestational age, within first 7 days of life, having echocardiographic features (given below) along with any one of the following clinical features of PPHN:
- •oxygenation index (OI) greater than 10;
- •fractional of inspired oxygen greater than 0.30; OR labile SpO2 with differential pre- and post-ductal SpO2 greater than 5%
- •(any two of the following echocardiographic parameters:
- •Pulmonary Artery pressure (PAP) more than 30 mmHg
- •PAP means Tricuspid regurgitation (TR) gradient plus RAP (where RAP is right atrial pressure (usually 5-10 mmHg);
- •Bidirectional flow or right to left shunt at PDA, PFO, ASD, or VSD;
- •Ratio of pulmonary artery acceleration time (PAAT) to right ventricular ejection time (RVET): PAAT/RVET less than 0.3;
- •Eccentricity index of LV at end systole more than 1;and
- •Dilated RA and RV.
排除标准
- •Congenital diaphragmatic hernia
- •Major congenital anomalies including structural heart disease except PDA, PFO, VSD or ASD
- •Altered GI aspirates
研究者
相似试验
撤回
3 期
Study Evaluating the Addition of Sildenafil to Bosentan Therapy in Pulmonary Arterial HypertensionHypertension, PulmonaryNCT00780728University Health Network, Toronto
尚未招募
不适用
To compare oral Sildenafil and Bosentan in the treatment of pulmonary hypertension in neonatesCTRI/2022/06/043328Department of Neonatology
已完成
2 期
Comparison of Bosentan and Sildenafil in the treatment of persistent pulmonary hypertension of the newborIRCT20190127042504N1Iran University of Medical Sciences50
进行中（未招募）
不适用
Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxinsMedDRA version: 9.1Level: LLTClassification code 10064908Term: Associated with (APAH)MedDRA version: 9.1Level: LLTClassification code 10064910Term: Familial (FPAH)MedDRA version: 9.1Level: LLTClassification code 10064909Term: Idiopathic (IPAH)EUCTR2005-005068-97-CZActelion Pharmaceuticals Ltd.350
进行中（未招募）
不适用
Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxinsMedDRA version: 9.1Level: LLTClassification code 10064908Term: Associated with (APAH)MedDRA version: 9.1Level: LLTClassification code 10064909Term: Idiopathic (IPAH)MedDRA version: 9.1Level: LLTClassification code 10064910Term: Familial (FPAH)EUCTR2005-005068-97-SEActelion Pharmaceuticals Ltd.350