EUCTR2017-004909-41-NO进行中（未招募）1 期
PRevention of cArdiac Dysfunction during Adjuvant breast cancer therapy:A Randomized, Placebo-controlled, Multicenter Trial - PRADA II
Akershus University Hospital Trust (HF)0 个研究点目标入组 300 人开始时间: 2018年1月17日最近更新:
适应症
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
- 300
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
- Female
入选标准
- •- Women with histological evidence of invasive early breast cancer scheduled for adjuvant therapy with anti-cancer regimens that include anthracyclines
- •- Eastern Cooperative Oncology Group performance status 0-1
- •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 270
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •- Age <18 years
- •- Renal failure, i.e. serum creatinine greater than 133 umol/L (1,5 mg/dl) or estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73m2
- •- Hyperkalemia, i.e. serum potassium greater than 5.0 mmol/L
- •- Systolic blood pressure < 100 mg Hg
- •- Uncontrolled hypertension
- •- Acute myocardial infarction within the last three months
- •- Contraindication to angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) or sacubitril/valsartan, including previous hypersensitivity reaction, angioedema and renal artery stenosis
- •- ACEI, ARB, or aldosterone antagonist use within 4 weeks of study start
- •- Clear indication for ACEI, ARB, or aldosterone antagonist therapy, including symptomatic heart failure
- •- History of hemodynamically significant valvular disease
- •- Active liver disease, i.e. alanine aminotransferase or aspartate aminotransferase greater than 1.5 times the upper limit of normal
- •- Participation in another pharmaceutical clinical trial of an investigational medicinal product less than 4 weeks prior to inclusion or use of other investigational drugs within 5 half-lives of enrollment, whichever is longer
- •- Psychiatric or mental disorders, alcohol abuse or other substance abuse
- •- Language barriers or other factors which makes adherence to the study protocol difficult
- •- Suspected poor drug compliance
- •- Contraindication or inability to undergo CMR examination. Patients who are unable to complete the baseline CMR investigation will be excluded
- •- Pregnancy or breastfeeding
- •- Life expectancy < 12 months
研究者
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