EUCTR2017-004656-30-ES进行中（未招募）1 期
EVOlocumab in stable Heart Failure with reduced ejection fraction of ischemic etiology: EVO-HF Pilot - EVO-HF pilot
Instituto de Investigación en Ciencias de la Salud Germans Trias i Pujol (IGTP)0 个研究点目标入组 56 人开始时间: 2018年9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
- 56
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. Signing of the informed consent
- •2. Patient =18 years and =80 years of age
- •3. LVEF <40%
- •4. Ischemic etiology (evidence of at least one acute coronary event and/or CAD by coronary angiography or multi slice CT)
- •5. New York Heart Association (NYHA) class II
- •6. NT-proBNP =600 pg/mL
- •7. Hs-TnT >14 pg/mL
- •8. LDL = 100 mg/dL
- •9. Stable CAD (last ACS before the last 3 months)
- •10. GDMT according to 2016 ESC HF guidelines for at least the last 3 months.
- •11. Statin treatment, whichever dose the patient receives at the time of enrolment, stable for at least 1 month, without need to statin uptitration
- •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 28
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 28
排除标准
- •1. Extracardiac disease with estimated life expectancy less than 1 year
- •2. Contraindication to receiving evolocumab
- •3. Hypersensitivity to the active substance or to any of the excipients
- •4. Female subject who has not used an acceptable method of birth control for at least 1 month prior to screening and/or is not willing to inform her partner of her participation in this clinical trial and to use an acceptable method of effective birth control during treatment with evolocumab and for an additional 15 weeks after the end of treatment with evolocumab, unless the female subject is permanently sterilized or postmenopausal:
- •A female is considered of childbearing potential unless permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or postmenopausal with menopause defined as:
- •- Age =55 years and =12 months of spontaneous and continuous amenorrhea, or
- •- Age <55 years but no spontaneous menses for =2 years, or
- •- Age <55 years and spontaneous menses within the past 1 year, but currently amenorrheic, AND with follicle-stimulating hormone (FSH) levels >40 IU/L or estradiol levels <5 ng/dL or according to the definition of postmenopausal range” for the laboratory involved.
- •5. Patient <18 or =81 years
- •6. Liver dysfunction (AST or ALT> 3 times the upper limit of normal value).
- •7. Severe renal dysfunction (estimated glomerular filtration rate [eGFR] < 30 ml/min/1.73m²) or renal replacement therapy at screening (CKD-EPI equation).
- •8. Coronary revascularization in the 3 months prior to randomization or pending coronary revascularization.
- •9. Previous haemorrhagic stroke
- •10. Uncontrolled hypertension (systolic blood pressure = 140 or/and diastolic blood pressure = 90 mmHg) either on or off therapy at screening or at baseline
- •11. Uncontrolled hypothyroidism or hyperthyroidism
- •12. Type 1 diabetes; newly diagnosed or poorly controlled type 2 diabetes (HbA1c > 8.5%)
- •13. Uncontrolled cardiac arrhythmia
研究者
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