NL-OMON50595招募中2 期
ERtugliflozin triAl in DIabetes with preserved or reduced ejeCtion FrAcTion;mEchanistic evaluation in Heart Failure: "ERADICATE-HF" - ERADICATE-HF
Toronto General Hospital/University Health Network0 个研究点目标入组 18 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Men and women with type 2 diabetes > 12 months, eGFR > 30 ml/min/1.73m2, age >
- •18 years, HbA1c 6.5 - 10.5%, BMI 18.5-45.0 kg, blood prssure < 160/110 and >
- •90/60 at screening, heart failure NYHA 2-3 with ejection fraction > 20%,
- •ACE/ARB-inhibition > 30 days, if diuretics are use then > 30 days before
- •baseline, BNP levels at baseline >100 pg/ml (no atrial fibrillation), >200
- •pg/ml if in atrial fibrillation, if NT-pro-BNP is used then a cut-off baseline
- •of >300ng/L (no atrial fibriallation) or >600 ng/L (in atrial fibrillation)
- •should be used
排除标准
- •1. Type 1 Diabetes;2. Leukocyte and/or nitrite positive urinalysis that is
- •untreated;3. Severe hypoglycaemia within 2 months prior to screening;4. History
- •of brittle diabetes or hypoglycaemia unawareness based on investigator
- •judgement;5. Unstable coronary artery disease with acute coronary syndrome,
- •percutaneous intervention or bypass surgery within 3 months;6. Clinically
- •significant valvular disease;7. Congestive heart failure secondary to an
- •infiltrative cardiomyopathic process (for example amyloid) or pericardial
- •constriction;8. Uncontrolled systemic hypertension (systolic blood pressure
- •> 160 mmHg and/or diastolic blood pressure >110) or systemic
- •hypotension(systolic blood pressure < 90/60 mmHg);9. Bariatric surgery or
- •other surgeries that induce chronic malabsorption;10. Anti-obesity drugs or
- •diet regimen and unstable body weight three months prior to screening;11.
- •Treatment with systemic corticosteroids;12. Blood dyscrasias or any disorders
- •causing hemolysis or unstable red blood cells;13. Pre-menopausal women who are
- •nursing, pregnant, or of childbearing potential and not practicing an
- •acceptable method of birthcontrol;14. Participation in another trial with an
- •investigational drug within 30 days of informed consent;15. Alcohol or drug
- •abuse within three months prior to informed consent that would interfere with
- •trial participation or any ongoing clinicalcondition that would jeopardize
- •subject safety or study compliance based on investigator judgement;16. Liver
- •disease, defined by serum levels of alanine transaminase, aspartate
- •transaminase, or alkaline phosphatase >3 x upper limit ofnormal as
- •determined during screening;17. Active malignancy at the time of screening;18.
- •Allergy to iodine-based substances if receiving iohexol for GFR measureseen
- •stenose > 30% vertoont;
- •6. De doellae
研究者
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