IRCT20231014059713N1招募中3 期
Efficacy of empagliflozin in prevention of Doxorubicin-induced cardiotoxicity in patients with breast cancer and receiving AC regimen (Cyclophosphamide + Doxorubicin): a randomized, placebo-controlled, double-blind trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 64
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
- 年龄范围
- 18 years 至 no limit（—）
- 性别
- Female
入选标准
- •A known case of breast cancer and candidate for receiving AC regimen
- •Signing a written informed consent to participate in the study
- •Patient age = 18
- •Ability to take oral medicine
- •ECOG performance status less than or equal to 2
排除标准
- •A history of breast cancer or a history of receiving chemotherapy regimen containing anthracycline or other chemotherapy drugs causing cardiomyopathy before entering the study
- •Inability to assess left ventricular (LV) function
- •Previous history of chest radiation therapy
- •Evidence of heart failure or left ventricular dysfunction based on echocardiography
- •Diagnosis or history of cardiomyopathies
- •Significant coronary artery disease (history of coronary stenting or stenosis based on previous angiography, history of known IHD or MI)
- •Severe valvular heart disease
- •Cardiac arrhythmia such as atrial fibrillation
- •Symptomatic hypotension or blood pressure less than 90 mmHg at the first visit
- •Liver enzymes more than 3 times ULN before entering the study
- •Significant renal failure (GFR less than 20 ml/min/1.73m2 with CKD-EPI formula) or need for dialysis
- •Simultaneous use of other drugs that can affect parameters of the study (such as ACEi, ARB, beta blockers)
- •Breastfeeding
- •Hypersensitivity to SGLT2 inhibitor drugs
- •History of treatment with SGLT2 inhibitors during the last 3 months before the start of the study
- •Participation in other clinical studies simultaneously
研究者
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