IRCT20190122042450N2招募中3 期
Effect of Empagliflozin on diastolic function and renal dynamics and biochemical parameters in people with heart failure with preserved ejection fraction
Abidi pharmacy0 个研究点目标入组 200 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
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
- 40 years 至 80 years（—）
- 性别
- All
入选标准
- •Heart Failure Preserved Ejection Fraction : HF symptom NYHA Class 2 or 3 and Ejection Fraction=50 by Echocardiography and BNP ( B type Natriuretic Peptide) >100 pg/mL within 2 month prior to enrollment
- •The ability to walk more than 50 meters
- •No significant changes in diuretic dosage (doubling dose or new prescription) within 1 week prior to enrollment
排除标准
- •Poor echocardiography finding
- •History of cancer within 3 years prior to enrollment
- •Uncontrolled hypothyroidism (TSH>4.5) or Hyperthyroidism (TSH<0.4)
- •Sever hepatic failure (Liver enzyme >3 ULN)
- •History of taking Pioglitazone within 8 weeks prior to enrollment
- •Myocardial infraction, unstable angina, percutaneous coronary intervention, or coronary bypass surgery within 60 days prior to enrollment
- •Decompensated heart failure within 4 weeks prior to enrollment
- •??An estimated glomerular filtration rate (eGFR) of at least 30 ml per minute per 1.73 m2 body- surface area, according to CKD-EPI formula.
- •Pregnancy and/or lactation
- •History of alcohol and other substance abuse
- •Active or recent (within 2 weeks prior to enrollment) genitourinary infection
- •Don't have compliance to taking medicine
- •History of including in another study within 3 month prior to enrollment
- •Start Angiotensin-Converting Enzyme (ACE) inhibitors, Hydralazine, long-acting nitrates, beta blockers ?? Angiotensin Receptor Blockers (ARBs) within 1 month prior to enrollment
- •History of allergy with Empagliflozin
- •History of taking Empagliflozin within 12 week prior to enrollment
- •Active gross hematuria
- •History of heart or kidney transplant
- •HF because of restrictive cardiomyopathy, active myocarditis, ,Constrictive Pericarditis, Sever valvular heart stenosis & hypertrophic cardiomyopathy
- •Uncontrolled Systolic Blood Pressure = 180 mmHg in two outpatient visit
- •Symptomatic hypotension or SBP < 100 mmHg
- •In type 2 diabetes patients who have been treated with at least one blood glucose lowering agent (oral, non-insulin) with any dosage change, within 12 weeks prior to enrollment
- •In type 2 diabetes patients daily dose of insulin would be changed exceed 10% of the base dose within 3 months before screening
- •7.5% > HbA1c >9.5% within 3 months before screening in type 2 diabetes patients
研究者
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