KCT0005166招募中未知
Impact of sodium-glucose transportation protein 2 inhibitor therapy on Diastolic hEart function and left AtriaL pressure in Atrial Fibrillation
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 0No Limit(—)
- 性别
- All
入选标准
- •?Subjects with = 19 years of age
- •?Documented atrial fibrillationon any form of electrocardiography.
- •?Type 2 diabetes mellitus by American diabetic association diagnostic criteria (Fasting glucose=126mg/dL or 2-h PG=200mg/dL or HbA1C >6.5%)
- •?HbA1C =7.5% before oral hypoglycemic agent or HbA1C 7.0-10.0% with one or more oral hypoglycemic agent (metformin or sulfonylurea)
- •?Agreement with protocol and providing informed consent
排除标准
- •?Subject with conflict of interest
- •?The subject who unable to provide informed consent or participating in the follow-up.
- •?Prior use of sodium-glucose transport protein-2 inhibitor or Dipeptidyl peptidase-4 inhibitor
- •?HbA1C = 10% or requiring insulin therapy for glucose management
- •?Contraindications to the sodium-glucose transport protein-2 inhibitor or Dipeptidyl peptidase-4 inhibitor (hypersensitivity or Creatinine clearance < 30ml/min)
- •?Active liver disease or laboratory abnormality (ALT or AST > x3 normal range)
- •?Severe congestive heart failure (New York Heart associationClass III or IV)
- •?Underlying conditions affect the primary outcome of the study (E/e') - Uncontrolled tachycardia, Mitral stenosis or regurgitation, prior mitral surgery, calcification of mitral annulus, left bundle branch block, aortic regurgitation
- •?Active malignancy.
- •?Pregnant and or lactating women
- •?Life expectancy < 1 year
- •? Not suitable for participation by the investigator's discretion
研究者
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