EUCTR2018-002979-17-DE进行中（未招募）1 期
se of doxapram as a new antiarrhythmic drug for a specific therapy of atrial fibrillation - Doctos Trial (DOxapram Conversion TO Sinus rhythm study)
Ruprecht-Karls University Heidelberg Medical Faculty, University Hospital0 个研究点目标入组 40 人开始时间: 2018年11月7日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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
- •1. Age 18 – 80 years,
- •2. Patient meets in-house eligibility criteria for non-emergent, electrical or pharmacological cardioversion (absence of AF-inducing medical conditions such as e.g. valvular disease, sufficient anticoagulation, and/or exclusion of cardiac thrombus),
- •3. Available previous ECG in sinus rhythm to allow for an assessment of QT time,
- •4. Ability to understand and willingness to comply with study interventions, and
- •5. Voluntarily signed informed consent after full explanation of the study to the patient.
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1. Any participation in a clinical drug trial within 5 times the documented terminal half-life of the respective active drug or if half-life is unknown within the last four weeks before inclusion,
- •2. Any physical disorder as judged by the investigator that could interfere with the patient’s safety during the clinical trial or with the study objectives,
- •3. Inability to communicate well with the investigator due to language problems or poor mental development,
- •4. Pregnancy or lactation,
- •5. Intake of antiarrhythmic agents as co-medication (Vaughan Williams classification), except class II beta-blockers, within less than 5 half-lives of the respective drug as related to planned exposure:
- •class Ia: e.g. quinidine, ajmaline, procainamide, or disopyramide,
- •class Ib: e.g. lidocaine, phenytoin, mexiletine, or tocainide,
- •class Ic: e.g. encainide, flecainide, propafenone, or moricizine,
- •class III: e.g. amiodarone, sotalol, ibutilide, dofetilide, dronedarone, or vernakalant,
- •class IV: e.g. verapamil ordiltiazem,
- •class V: e.g. adenosine, digoxin, or digitoxin,
- •unclassified: ranolazine,
- •6. Any adenosine like drugs (e.g. ticagrelor) within less than 5 half-lives of the respective drug,
- •7. Any magnesium intake (> 500 mg) within 4 h of planned exposure, if magnesium has been applied within 24 h prior to planned exposure magnesium blood level must not higher than the upper limit of normal (+ 10%),
- •8. Any theophylline intake within 3 d as related to planned exposure,
- •9. Contraindication for doxapram use present such as
- •a) known intolerance to doxapram,
- •b) systolic blood pressure < 100 mmHg or > 170 mmHg,
- •c) diastolic blood pressure < 60 mmHg or > 100 mmHg,
- •d) Heart rate < 50 / min,
- •e) acute coronary syndrome,
- •f) decompensated heart failure or chronic heart failure (NYHA) class III or IV,
- •g) hyperthyreodism,
- •h) history of pheochromocytoma,
- •i) impaired breathing function (due to a history of e.g. accidental injury, pneumothorax, pulmonary embolism, neuromuscular impairment, lung fibrosis, asthma, or other impairment of breathing),
- •j) history of epilepsy or other convulsive disorders,
- •k) history of cerebral injury, cerebral edema, cerebral ischemia or cerebral bleeding,
- •10. Any emergency situation which requires emergency treatment,
- •11. Any immediate need of sympathomimetics, monoaminooxidase inhibitors, halothane, isoflurane, enflurane, theophylline,
- •12. Hemoglobin < 10 g/dl,
- •13. Known channelopathy, or
- •14. Signs of long QT syndrome (male participants with QTc > 430 ms, female participants with QTc > 450ms) or short QT syndrome in an ECG in sinus rhythm recorded.
- •15. Body weight > 140 kg
研究者
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