Pulmonary Capillary Recruitment With Pulmonary Vasodilator Therapy in Patients With Univentricular Heart Physiology and Failing Total Cavo-pulmonary Connection.
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Functional capillary surface area
研究概览
简要总结
This study evaluates the effects of pulmonary vasodilator therapy on pulmonary capillary blood flow by measuring the functional capillary surface area (FCSA) at baseline and post nitric oxide inhalation, through the injection of 3H-benzoyl-Phe-Ala-Pro (BPAP). FCSA will be related to flow and other hemodynamic parameters in order to determine if there is capillary recruitment or distention in Fontan patients. We will also compare baseline FCSA measurements with previously studied normal subjects, to assess the difference in hemodynamic pulmonary functional parameters between these single ventricle physiology patients and normal subjects.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fontan failures will be defined as patients with single ventricle physiology and TCPC with clinical signs of dysfunction defined as any of the following:
- •Decreased functional class WHO/NYHA II or more and clinical signs of congestion (ascites, peripheral edema, increased JVP) and/or NT-proBNP > 399 pg/ml based on [17].
- •Age > 18 years
- •Known Fontan's increased pressures a. Fontan mean pressure of ≥15 mmHg and/or transpulmonary gradient ≥ 5 mmHg. b. Pulmonary vascular resistance ≥ 2 woods units. And/or supporting evidence of end-organ damage
- •Clinical or paraclinical evidence of liver congestion and/or fibrosis
- •a. Evidence in ultrasound or other imaging techniques of liver congestion and/or changes related to cardiac cirrhosis.
- •b. Fibroscan with grade 2 or +
- •Paraclinical signs of portal hypertension defined as 2 or more:
- •Thrombocytopenia defined as platelet count < 150.0000
- •Leukocytopenia defined as white blood cell less than 4.500
- •Esophageal varices on esophagoduodenoscopy.
- •Splenomegaly on imaging -
排除标准
- •Presence of fenestration - the shunts include veno-veno collaterals
- •Significant anemia defined as Hgb < 120 mg/dl
- •Pregnancy at the moment of the procedure.
- •Taking angiotensin-converting enzyme inhibitors or angiotensin receptor blockers.
- •Usage of nitrates, phosphodiesterase inhibitors or calcium blockers within 3 months of the study.
结局指标
主要结局
Functional capillary surface area
时间窗: 30 minutes
Measurement of functional capillary surface area pre and post inhaled nitric oxide
次要结局
未报告次要终点
研究者
Dr David Langleben
Professor of Medicine (Cardiology)
Jewish General Hospital