EUCTR2021-005394-66-IT进行中（未招募）1 期
Effects of Dapagliflozin on cardiac deformation and clinical outcomes in heart failure with reduced and mildly reduced ejection fraction - ESR-20-21070
AZIENDA OSPEDALIERA UNIVERSITARIA SENESE0 个研究点目标入组 88 人开始时间: 2021年11月23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
- 88
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
- •Patients can be included in the study only if they meet the following criteria:
- •1. Providing informed consent prior to any specific study procedure
- •2. Female or male non-diabetic outpatients> 18 years
- •3. Have heart failure with left ventricular ejection fraction <50%, according to the ESC definition [1], such as patients with signs (pulmonary crepitus, peripheral edema, elevated jugular venous pressure) and / or symptoms (dyspnoea, fatigue, ankle swelling) of heart failure, left ventricular ejection fraction <40% or 40-49%.
- •4. Already on OMT according to ESC HF guidelines [1] (for HFrEF this mainly includes an angiotensin converting enzyme (ACE) inhibitor or sacubitril / valsartan, a beta blocker and a mineralocorticoid receptor antagonist (MRA)).
- •5. Subjects without severe chronic kidney disease (eGFR with CKD-EPI formula must be = 30 mL / min)
- •6. Negative pregnancy test (urine or serum) for female subjects of childbearing age.
- •7. Female subjects must be 1 year postmenopausal, surgically sterile, or use an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in combination with a spermicide) for the duration of the study (from sign the consent) and for 3 months after the last dose of Drug A / placebo to prevent pregnancy. Also, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; Additional barrier methods should be used in combination with the spermicide.
- •8. Male subjects must be surgically sterile or use an acceptable method of contraception (defined as barrier methods in combination with spermicides) for the duration of the study (from the time they sign the consent) and for 3 months after the last drug dose A / placebo matching to prevent pregnancy in a partner.
- •9. Subjects who are blood donors should not donate blood during the study and for 3 months after their last dose of Drug A.
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 68
排除标准
- •Patients cannot be included in the study if only one of the following exclusion criteria is present:
- •1. Involvement in study planning and / or conducting (applies to both investigator staff and study site staff)
- •2. Previous enrollment or randomization in the present study
- •3. Participation in another clinical study with an investigational product within the past 6 months
- •4. Previous treatment with any SGLT2 inhibitor
- •5. Type II diabetes mellitus
- •6. Atrial fibrillation at the time of enrollment
- •7. Chronic kidney damage with creatinine clearance <30 ml / min (calculated from the CKD-EPI formula)
- •8. <18 years
- •9. For women only - ongoing pregnancy (confirmed with positive pregnancy test)
- •10. For women only - breastfeeding
- •11. Poor quality of echocardiographic images that compromises a correct speckle tracking analysis
- •12. Failure to sign informed consent
- •13. Persistent toxicities (> CTCAE grade 2) caused by previous anticancer therapies, excluding alopecia
- •14. Patients on dialysis
- •15. Patients with known hypersensitivity to Dapagliflozin or to any of the excipients of the product
- •16. Any concomitant drug known to be associated with Torsades de pointes or potent inducers of cytochrome P450 3A4 (CYP3A4)
- •17. History of QT prolongation associated with other drugs that required discontinuation of that drug
- •18. Congenital long QT syndrome
- •19. History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE grade 3) or asymptomatic sustained ventricular tachycardia
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