EUCTR2018-000263-92-FR进行中（未招募）1 期
Spironolactone and perioperative atrial fibrillation occurrence in cardiac surgery patients: a multicenter randomized, double-blind study - ALDOCURE
CHU CAE0 个研究点目标入组 1,500 人开始时间: 2018年3月28日最近更新:
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
- 1,500
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
入选标准
- •Male or female; Age > 18 years
- •Elective CABG surgery ± AVR
- •In sinus rhythm
- •Patient signed consent
- •Willing to comply with scheduled visits, as outlined in the protocol
- •French nationality
- •Recipients of the social security regime
- •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 1500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1500
排除标准
- •Contraindications to spironolactone therapy: intolerance, hyperkalemia (>5.0 mmol/L), severe renal dysfunction (defined as an estimated glomerular filtration rate (eGFR) < 30 ml/min (per the Modification of Diet in Renal Disease (MDRD) 4-component study equation). Subjects with serum creatinine =2.5 mg/dl are also excluded even if their eGFR is =30 ml/min), Severe liver dysfunction (Child-Pugh Class 3), patients treated by other potassium sparing medication (except in case of hypokalemia).
- •Patients treated by MRA treatment (spironolactone or eplerenone)
- •Left ventricular ejection fraction < 50% obtained within 6 months prior to V0
- •Mitral valve surgery associated to the CABG
- •Off-pump beating or emergency CABG
- •History of AF or another atrial arrhythmia
- •Presence of antiarrhythmic medication (other than ß-blockers)
- •Previous heart surgery and heart transplant recipient
- •Unstable conditions: angina or acute coronary syndrome or heart failure during the last 3 months, cardiogenic shock
- •Patients included or planning to be included in another medical research protocol
- •Patients unable to complete the protocol follow-up
- •Pregnant or nursing women
- •Adults with protective measures (curatorship or tutorship)
研究者
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