2024-515323-11-00招募中2 期
Prevention of cardiac Dysfunction during Adjuvant breast cancer therapy: A Randomized, Placebo-controlled, Multicenter Trial (PRADA-II)
Akershus University Hospital4 个研究点 分布在 1 个国家目标入组 214 人开始时间: 2018年12月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 214
- 试验地点
- 4
- 主要终点
- Change in left ventricular ejection fraction (LVEF), as determined by CMR from randomization to end of blinded therapy (18 months).
研究概览
简要总结
In patients with early breast cancer scheduled for anthracycline-containing anti-cancer therapy, to assess whether the administration of LCZ696 (sacubitril/valsartan) can prevent or is associated with attenuation of the reduction in left ventricular systolic function measured by cardiovascular magnetic resonance (CMR).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with histological evidence of invasive early breast cancer scheduled for neoadjuvant and/or adjuvant therapy with anti-cancer regimens that include anthracyclines.
- •Eastern Cooperative Oncology Group performance status 0-
- •Sinus rhythm.
排除标准
- •Age <18 years
- •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
- •Conditions that would affect the participants to comply with the study protocol as psychiatric or mental disorders, alcohol abuse or other substance abuse, suspected poor drug compliance, language barriers or other factors
- •Contraindication or inability to undergo CMR examination
- •Fertile women with inadequate birth control, pregnancy, and/or breastfeeding. Adequate contraception includes oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or system, vasectomized partner or sexual abstinence. Fertile women are defined as following menarche and until becoming postmenopausal unless permanently sterile. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause
- •Life expectancy < 12 months
- •Renal failure, i.e. serum creatinine greater than 133 micromol/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 LCZ696, including previous hypersensitivity reaction, angioedema and renal artery stenosis
- •ACEI, ARB, aldosterone antagonist or LCZ696 use within 4 weeks of study start
- •Clear indication for ACEI, ARB, aldosterone antagonist or LCZ696 therapy, including symptomatic heart failure
结局指标
主要结局
Change in left ventricular ejection fraction (LVEF), as determined by CMR from randomization to end of blinded therapy (18 months).
Change in left ventricular ejection fraction (LVEF), as determined by CMR from randomization to end of blinded therapy (18 months).
次要结局
- Change in left ventricular ejection fraction (LVEF), as determined by echocardiography from randomization to end of blinded therapy (18 months).
- Change in global longitudinal strain (GLS), as determined by echocardiography from randomization to end of blinded therapy (18 months).
- Change in GLS, as determined by CMR from randomization to end of blinded therapy (18 months)
- Change in end-systolic volume measured by CMR.
- Incidence of clinically significant reduction in left ventricular systolic function expressed as an absolute reduction in LVEF >/=5% by CMR.
- Incidence of clinically significant reduction in left ventricular systolic function expressed as a relative percentage reduction of GLS > 15%
- Incidence of cardiotoxicity expressed as an absolute reduction in LVEF >/=10% to a value below 50% as measured either by CMR or Echocardiography.
- Incidence of cardiotoxicity expressed as incidence of clinical heart failure.
- Cardiotoxic injury expressed as change in circulating concentrations of cardiac troponins I and T measured by high sensitivity assays (hs-TnI and hs-TnT) and N-terminal proB-type natriuretic peptide (NT-proBNP).
研究者
Torbjørn Omland
Scientific
Akershus University Hospital
研究点 (4)
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