EUCTR2017-001840-37-NL进行中（未招募）1 期
ERtugliflozin triAl in DIabetes with preserved or reduced ejeCtion FrAcTionmEchanistic evaluation in Heart Failure: ERADICATE-HF - ERADICATE-HF
VU University Medical Center0 个研究点目标入组 36 人开始时间: 2018年6月22日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
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. Male or female subjects diagnosed with T2D =12 months prior to
- •informed consent;
- •2. eGFR =30 ml/min/1.73m2;
- •3. Age >18 years;
- •4. HbA1c 6.5%-10.5%;
- •5. Body Mass Index (BMI) 18.5-45.0 kg/m2;
- •6. Blood pressure < 160/110 and > 90/60 at screening,
- •7. Heart failure with New York Heart Association (NYHA) class 2-3 symptoms and ejection fraction > 20%
- •8. Stable dose of maximally tolerated ACE inhibitor, angiotensin receptor blocker or renin inhibitor for at least 30 days
- •9. Stable diuretic dose for at least 30 days at the time of baseline physiological assessment
- •10. BNP levels at baseline > 100 pg/ml (no atrial fibrillation), > 200 pg/ml if in atrial fibrillation (if NT-pro-BNP is used then baseline should be >300 ng/L (no atrial fibrillation), or >600 ng/L (in atrial fibrillation)
- •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 6
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
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 birth
- •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 clinical
- •condition 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 of
- •normal as determined during screening;
- •17. Active malignancy at the time of screening;
- •18. Allergy to iodine-based substances if receiving iohexol for GFR measures
研究者
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