NCT04330079终止4 期
Effects of dapaglifloziN Therapy on Myocardial Perfusion Reserve in Prediabetic Patients With Stable coronarY Artery Disease (ENTRY Trial)
CHEOL WHAN LEE, M.D., Ph.D1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2020年5月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Percent change in global myocardial perfusion reserve (MPR) index
研究概览
简要总结
The purpose of this study is to investigate the effects of dapagliflozin therapy on myocardial perfusion reserve (MPR) using dynamic SPECT examination in prediabetic patients with stable CAD.
Dapagliflozin therapy versus lifestyle modification improves myocardial perfusion reserve in prediabetic patients with stable CAD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women at least 18 years of age
- •Prediabetes by ADA criteria (fasting glucose 100-125mg/dl, or HbA1C 5.7-6.4%)
- •Stable coronary artery disease
- •Global myocardial perfusion reserve (MPR) index < 2.0
- •The patient or guardian agrees to the study protocol and the schedule of clinical and dynamic SPECT follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
排除标准
- •Contraindications to dapagliflozin
- •Significant renal disease manifested by eGFR<30 ml/min/1.73m²
- •Unstable or rapidly progressing renal disease
- •Acute coronary syndrome, or any other major cardiovascular events within the previous 6 months
- •Stent placement, or coronary artery bypass graft surgery within the previous 6 months
- •Planned revascularization within 6 months
- •Significant disease (diameter stenosis >70% by coronary CT angiography) in major epicardial coronary arteries
- •Heart failure requiring loop diuretics
- •Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 3 times upper limit of normal).
- •Contraindication to adenosine stress test
- •Current treatment for the active cancer
- •Women of child bearing potential who are not willing to use a medically accepted method of contraception. Patient's pregnancy confirmed by positive pregnancy test, or breast-feeding.
- •Expected life expectancy < 1 year
- •Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests which, in the judgment of the investigator, would preclude safe completion of the study.
- •Unwillingness or inability to comply with the procedures described in this protocol.
研究组 & 干预措施
Dapagliflozin
Experimental
干预措施: Dapagliflozin 10mg (Drug)
Lifestyle modification
Other
干预措施: Lifestyle modification (Other)
结局指标
主要结局
Percent change in global myocardial perfusion reserve (MPR) index
时间窗: 6months
次要结局
- Percent change in regional myocardial perfusion reserve (MPR) index(6months)
- Change in body weight(6months)
- absolute changes in global MPR index(6months)
- absolute changes in regional MPR index(6months)
- Change in blood pressure(systolic, diastolic both )(6months)
研究者
CHEOL WHAN LEE, M.D., Ph.D
Professor
Asan Medical Center
研究点 (1)
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