EUCTR2019-003888-22-HR进行中（未招募）1 期
A multicENter, randomized, open-label, parallel group, pilot study to evaluate the use of sacubitril/valsartan in HeartMate 3 LVAD recipients - ENVAD-HF
niversity of Zagreb School of Medicine0 个研究点目标入组 60 人开始时间: 2020年11月19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
- 60
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. Written informed consent must be obtained before any assessment is performed.
- •2. =18 years of age, male or female
- •3. Recently implanted HeartMate 3 LVAD recipients, in stable condition and deemed ready for discharge or chronic, stable, ambulatory HeartMate 3 LVAD carriers implanted within 1 year prior to enrolment
- •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 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. Current acute decompensated HF (including right ventricular failure) requiring therapy with intravenous diuretics or vasodilators and/or inotropic drugs within the past 48 hours
- •2. History of hypersensitivity to sacubitril/valsartan or to drugs of similar chemical classes, patients with a known history of angioedema
- •3. Patients with mean blood pressure =75 mmHg (systolic blood pressure i.e. Doppler opening blood pressure =90 mmHg in those pulsatile and measured by Doppler method) or symptomatic hypotension
- •4. eGFR < 30 mL/min/1.73m2 as calculated by the Modification in Diet in Renal Disease (MDRD) formula at Visit 1
- •5. Patients with serum potassium >5.4 mmol/L (mEq/L) at Visit 1
- •6. Hemodynamically unstable patients or those with ongoing MCS other than LVAD or those with planned biventricular support
- •7. Hemodynamically significant aortic insufficiency in the opinion of the investigator
- •8. Irreversible end-organ dysfunction
- •9. Previous sacubitril/valsartan use while on LVAD support
- •10. Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major CV surgery, percutaneous coronary intervention (PCI) or carotid angioplasty within 30 days prior to enrolment
- •11. Life-threatening or uncontrolled dysrhythmia, including symptomatic or sustained ventricular tachycardia and atrial fibrillation or flutter with a resting ventricular rate >110 bpm at enrolment
- •12. Any surgical or medical condition, which in the opinion of the Investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study
- •13. Active infection with hemodynamic compromise
- •14. Hemoglobin (Hgb) <8 g/dl
- •15. Body mass index (BMI) > 45 kg/m2
- •16. Congenital heart disease
- •17. Coronary or carotid artery disease or valvular heart disease likely to require surgical or percutaneous intervention within the 6 months after enrolment
- •18. Evidence of hepatic disease as determined by any one of the following: SGOT (AST) or SGPT (ALT) values exceeding 3x ULN, bilirubin >1.5 mg/dl at Visit 1
- •19. Pregnant or nursing (lactating) women and women of child-bearing potential unless they are using highly effective methods of contraception
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