Effect of Endothelin Receptor Antagonist Bosentan in Glucose Metabolism of the Myocardium and Coronary Dependant Endothelial Vasoreactivity Measured by 18F-FDG PET / CT and 82Rb PET / CT in Patients With PAH or CTEPH
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- On the images 82Rb PET/CT rest MBF
研究概览
简要总结
The purpose of this study is to assess the effect of bosentan on the myocardial metabolism and the dependent endothelial coronary vasomotoricity in patients presenting a PAH.
Hypothesis : Bosentan may improve right ventricular function by decreasing myocardial stress and glucose metabolism. Patients may benefit from images with 18F-FDG PET / CT and 82Rb PET / CT for an earlier assessment and optimal management of PAH.
详细描述
Patients refered to the hospital for a right heart catheterization for a PAH suspected at the echocardiography will be presented with the protocol.If inclusion/exclusion criteria are fulfilled all the procedures will be planned. At the screening visit the patient will have a right heart catheterization and an echocardiography. After a maximum of 4 weeks each patient will have 18F-FDG and 82Rb PET/CTs before start of treatment with Bosentan. These PET/CTs together with an echocardiography will be repeated at 6 and 12 weeks after start of treatment with bosentan.
Finally a right heart catheterization will be planned at 12 weeks after start of treatment with bosentan as a routine procedure.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic PAH (PH group 1 Dana Point / stages 2 à 4 according to NYHA classification, defined by a mean arterial pulmonary pressure >25 millimeter of mercury (mmHg) at rest, an occlusion arterial pulmonary pressure <15 millimeter of mercury (mmHg) and vascular pulmonary resistance >240 dyn.s.cm-5 for which a treatment with bosentan is indicated Or Patients with CTEPH not candidate for a pulmonary endarterectomy or patient with residual CTEPH after pulmonary endarterectomy (PH group 4 Dana Point / stages 2 to 4 according to NYHA classification) and for which a treatment with bosentan is indicated
- •Indication to perform a right heart catheterization in the context of PAH suspected during cardiac ultrasound
- •Age from 18 to 80 years old, male and female
- •Karnofsky index ≥80%
- •Informed consent signed
排除标准
- •Patients with PAH stages 2,3 or 5 of Dana Point
- •Patients with a contra-indication to adenosine including severe uncontrolled asthma, severe uncontrolled chronic obstructive pulmonary disease, 2nd or 3rd degree atrioventricular block without pacemaker,
- •Patients with a contraindication to Bosentan, i.e :hypersensibility to the product, hepatic failure Child Pugh B or C, aminotransferases >3 times normal value (N),association with cyclosporine A or glibenclamide
- •Pregnancy, female of child-bearing potential not using any acceptable contraceptive method, breastfeeding
- •Atrial fibrillation (Ventricular Ejection Fraction (VEF) not evaluable at echography)
- •Karnofsky index <80%
- •Impossibility to obtain informed consent signed
- •Left cardiopathies that can be responsible of post-capillar hypertension
- •Involvement in another clinical study with an unregistered drug within 30 days prior to this specific study and during the entire course of the study
- •Inability to comply with study procedures (linguistic problem, psychiatric problems, dementia, confusional state)
- •Known or suspected non compliance drug or alcohol abuse
- •Left heart assessment : diastolic and systolic function and valvular structures to exclude a cardiac pathology
结局指标
主要结局
On the images 82Rb PET/CT rest MBF
时间窗: at 12 weeks after start of treatment
myocardial blood flow (MBF in mL/min/g) at rest
Analysis of each method of imaging for assessment of myocardial metabolism
时间窗: at 12 weeks after start of treatment
On the images of au 18F-FDG PET/CT : myocardial ventricular right maximum standardized uptake value (SUVmax)
Analysis of each method of imaging for assessment of myocardial metabolism and endothelial dysfunction
时间窗: at 12 weeks after start of treatment
On the images of au 18F-FDG PET/CT : myocardial ventricular left maximum standardized uptake value (SUVmax)
On the images 82Rb PET/CT stress MBF
时间窗: at 12 weeks after start of treatment
myocardial blood flow (MBF in mL/min/g) at pharmacological stress
On the images 82Rb PET/CT, analysis of endothelial dysfunction cold test MBF
时间窗: at 12 weeks after start of treatment
myocardial blood flow (MBF in mL/min/g) at cold test
次要结局
- Analysis of right heart catheterization parameters PAP(at 12 weeks after start of treatment)
- Analysis of clinical parameters NT-pro-BNP(at 12 weeks after start of treatment)
- Analysis of right heart catheterization parameters PWP(at 12 weeks after start of treatment)
- Analysis of right heart catheterization parameters RAP(at 12 weeks after start of treatment)
- Analysis of clinical parameters LFT(at 12 weeks after start of treatment)
- Analysis of clinical parameters NYHA(at 12 weeks after start of treatment)
- Analysis of clinical parameters 6-min walk test(at 12 weeks after start of treatment)
研究者
John O. Prior
Chief of the Department of Nuclear medicine
University of Lausanne Hospitals