EUCTR2014-002590-10-FR进行中（未招募）1 期
Effect of bronchodilators on effort induced dyspnoea in patients suffering lung hypertension - BD-HTAP
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
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
- •Idiopathic or heritable PAH patients, clinically stable during the 3 preceding months, non/never smokers, with normal FEV1/VC ratio but FEF75% ? 60% predicted.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •1. Pregnant women
- •2. Past or current tobacco-smoking history,
- •3. A spirometric evidence of an obstructive ventilatory defect as defined by a reduced FEV1/VC ratio below the 5th percentile of the predicted value [43],
- •4. A FEF75% >60% of predicted normal values at spirometry,
- •5. A TLC below the 5th percentile of the predicted value [43],
- •6. A body mass index >30 kg.m-2,
- •7. Use of supplemental oxygen,
- •8. PAH induced by drugs and toxins,
- •9. PAH associated with other conditions, including connective tissue diseases, congenital heart diseases, portal hypertension, and HIV infection [42],
- •10. Chronic thromboembolic pulmonary hypertension [42],
- •11. Other respiratory, cardiac and other diseases that could contribute to dyspnoea or exercise limitation,
- •12. Contraindications to clinical exercise testing, such as NYHA functional class IV, syncope and others, as detailed page 28 elsewhere [26, 44].
- •1.NYHA functional class IV
- •3.Acute myocardial infarction (3-5 days)
- •4.Unstable angina
- •5.Uncontrolled arrhythmias causing symptoms or hemodynamic compromise
- •6.Uncontrolled heart failure
- •7.Active endocarditis
- •8.Acute myocarditis or pericarditis
- •9.Symptomatic severe aortic stenosis
- •10.Suspected dissecting aneurysm
- •11.Acute pulmonary embolus or pulmonary infarction
- •12.Thrombosis of lower extremities
- •13.Uncontrolled asthma
- •14.Pulmonary edema
- •15.Room air desaturation at rest <85%
- •16.Respiratory failure
- •17.Acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e. infection, renal failure, thyrotoxicosis)
- •18.Mental impairment leading to inability to cooperate
- •Relative Contraindications to clinical exercise testing:
- •Specific precision for exclusion criteria n°12: Absolute Contraindications to clinical exercise testing:
- •1. Left main coronary stenosis or its equivalent
- •2. Moderate stenotic valvular heart disease
- •3. Severe untreated arterial hypertension at rest (>200 mm Hg systolic, >120 mm Hg diastolic)
- •4. Tachyarrhythmias or bradyarrhythmias
- •5. High-degree atrioventricular block
- •6. Hypertrophic cardiomyopathy
- •7. Electrolyte abnormalities
- •8. Orthopedic impairment that compromises exercise performance
- •13. Specific contraindications (precautions and drug interactions) to the administration of IB or IB+SALB (please refer to section 7).
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