EUCTR2012-003335-33-GR进行中（未招募）1 期
A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Subjects:
- •not participating in the hemodynamic sub-study: males or females = 12 years of age.
- •participating in the hemodynamic sub-study: males or females = 18 years of age.
- •- Subjects (including those with Down Syndrome (DS)) with confirmed ES (European Society of Cardiology [ESC] and the European Respiratory Society [ERS] guidelines):
- •a) Established by echocardiography as:
- •Large congenital shunting defect at atrial, ventricular or arterial level*
- •and right to left shunt or bi-directional shunt with prevalent right to left direction.
- •b) Resting peripheral oxygen saturation (SpO2) = 90% and > 70% (pulse oximetry, room air).
- •The lower limit is 65% if a subject is living at an altitude greater than 2500 m above sea level.
- •*Subjects with any of the following open defects are eligible for the study either as an isolated defect or in combination:
- •atrial septal defect (ASD)
- •ventricular septal defect (VSD)
- •partial or complete atrioventricular septal defect (AVSD)
- •patent ductus arteriosus (PDA)
- •aortopulmonary window (AP window)
- •total or partial anomalous pulmonary venous return (TAPVR, PAPVR)
- •The defects may be either unoperated or previously palliated surgically (provided significant residual defect remains).
- •The Steering Committee will review the echocardiography data of all subjects (main study and sub study) to confirm eligibility prior to Randomization.
- •- Subjects with the following findings at Cardiac catheterization :
- •Mean resting pulmonary arterial pressure (mPAP) > 25 mmHg,
- •Pulmonary capillary wedge pressure (PCWP) or mean left atrial pressure (LAP) or left ventricular end diastolic pressure (LVED) = 15 mmHg,
- •Pulmonary vascular resistance (PVR) = 800 dyn·s/cm5 or = 10 Wood units.
- •- Subjects with WHO functional class = II.
- •- Subjects able to reliably perform the 6-minute walk test (6MWT) with a minimum distance of 50 m and a maximum distance of 450 m.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 15
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 190
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •- Main study and hemodynamic sub-study: Any of the following conditions previously known or identified via cardiac catheterization or echocardiography:
- •Pulmonary arterial or venous stenosis > 25% size of native pulmonary artery (PA)
- •Severe tricuspid regurgitation in the setting of left to right shunt at the ventricular or atrial level
- •Greater than mild tricuspid stenosis
- •Intracavitary RV outflow obstruction
- •Greater than mild mitral stenosis
- •Intracavitary LVoutflow obstruction
- •Subvalvular or supravalvular aortic stenosis
- •Aortic coarctation
- •Greater than moderate mitral regurgitation
- •Recognized extracardiac systemic venous collaterals to the pulmonary venous circulation
- •Recognized hepatic wedge pressure-inferior vena cava pressure gradient > 12 mmHg
- •PCWP v” waves >20 mmHg
- •Tetralogy of Fallot
- •Truncus arteriosus
- •Interrupted aortic arch
- •Transposition of the great arteries
- •Single ventricle defects: absent AV connection (mitral or tricuspid atresia), double inlet AV connections left or right ventricle, functional univentricular heart (unbalanced AVSD, hypoplastic RV, double outlet RV), hypoplastic left heart syndrome
- •Ebstein’s anomaly
- •Severe aortic regurgitation
- •Pulmonary atresia
- •PAPVR or TAPVR, ONLY if there is lung hypoplasia or if documentation confirming the absence of lung hypoplasia does not exist.
- •For subjects participating in the hemodynamic sub-study the following will also be considered exclusion criteria:
- •SVC stenosis > 25% size of native vessel.
- •PDA, aorto-pulmonary window, TAPVR, PAPVR, or ASD sinus venosus with anomalous pulmonary veins.
- •Down Syndrome
- •- Subjects with deterioration of their clinical status within 3 months prior to Screening or during the Screening period.
- •- Known moderate-to-severe restrictive (i.e., total lung capacity [TLC] < 60% of predicted value) or obstructive lung disease (i.e., forced expiratory volume in one second [FEV1] < 80 % of predicted value, and with FEV1 / forced vital capacity [FVC] < 70%).
- •- Treatment with prostanoids within 1 month prior to Randomization.
- •- Subjects who initiated a PDE-5 inhibitor within 1 month prior to Randomizationor those on a PDE-5 inhibitor for whom the dose has not been stable within 1 month prior to Randomization.
- •- Treatment with endothelin receptor antagonists (ERAs) within 1 month prior to Randomization.
- •- Subjects who initiated diuretics within 1 week prior to Randomization or subjects whose diuretic treatment has not been stable for at least 1 week prior to Randomization.
- •- Subjects being considered for an organ transplant.
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