ISRCTN13967269已完成未知
BENznidazole Evaluation For Interrupting Trypanosomiasis pilot trial
Hamilton Health Science Corporation (HHSC) (Canada)0 个研究点目标入组 600 人开始时间: 2007年6月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 600
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
- 性别
- All
入选标准
- •1. Either sex, aged greater than or equal to 18 and less than or equal to 70 years
- •2. At least two positive serological tests for Chagas disease (indirect immunofluorescence, indirect hemagglutination, OR Enzyme-Linked Immunosorbent Assay [ELISA]) and at least ONE of the following markers of cardiac involvement (which identify individuals at high risk of progression):
- •2.1. Abnormal 12 lead Electrocardiogram (ECG): One-major criteria (second or third degree AV block) OR at least two minor criteria:
- •2.1.1. Any bundle branch block
- •2.1.2. Any fascicular block
- •2.1.3. Ventricular premature beats (greater than one)
- •2.1.4. First degree AV block greater than 220 ms, in the absence of drugs that slow AV node conduction
- •2.1.5. Mobitz type I AV block, in the absence of drugs that slow AV
- •2.1.6. Sinus bradycardia less than 50 bpm or sinus pauses greater than 3.0s, in the absence of sinus node blocking drugs
- •2.1.7. Low voltage of QRS in the frontal plane
- •2.1.8. Atrial fibrillation
- •2.2. Increased cardiothoracic ratio greater than 0.50 at baseline on upright chest X ray
- •2.3. Evidence of regional wall motion abnormality (hypokinesis, akinesis or dyskinesis) or reduced global Left Ventricular Systolic Function (LVEF) less than 50% (2D-Echo Radionuclide Angiography [RNA] LV ventriculography) or increased left ventricular diastolic diameter (greater than 55 mm) on 2D-Echo
- •2.4. Complex ventricular arrhythmias (multiform greater than 10/hour, couplets or non-sustained Ventricular Tachycardia [NSVT]) on 24 hour ambulatory ECG monitoring
排除标准
- •1. New York Heart Association (NYHA) heart failure class IV or decompensated heart failure
- •2. Evidence of concomitant Coronary Artery Disease (CAD) or other etiology of dilated cardiomyopathy
- •3. Previous treatment with antitrypanosomal agents or an accepted indication for antiparasitic therapy (e.g. reactivation of Chagas infection due to immunosuppression by several diseases or treatment with steroids)
- •4. Patients living in inadequate housing conditions that may predispose to t. cruzi re-infection will not be excluded; instead this condition will be appropriately documented
- •5. Inability to comply with follow-up
- •6. History of severe alcohol abuse within two years
- •7. Known chronic renal insufficiency (serum creatinine greater than 2.5 mg/dl or 200 umol) or hepatic insufficiency (Aspartate Aminotransferase [AST]/Alanine Aminotransferase [ALT] greater than 3 x normal)
- •8. Pregnancy or breast feeding
- •9. Megaesophagus with swallowing impairment
- •10. Other severe disease significantly curtailing life expectancy
研究者
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