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 人待定
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Toronto General Hospital/University Health Network
- 入组人数
- 18
- 状态
- 招募中
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
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
结局指标
主要结局
未指定
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