JPRN-jRCTs051220140招募中Unknown
The effect of tofogliflozin on cardiac structure focusing on myocardial fibrosis in type 2 diabetes patients with nonalcoholic fatty liver disease at risk for heart failure
oguchi Michio0 个研究点目标入组 114 人开始时间: 2022年12月23日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 114
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
- >= 20age old 至 < 85age old（—）
- 性别
- All
入选标准
- •1 Patients aged >= 20 and < 85 years at the provision of written informed consent
- •2 Patients with type 2 diabetes mellitus
- •patients who need a new drug or the change of drugs for type 2 diabetes mellitus
- •patients who are possible to change drugs for type 2 diabetes mellitus
- •3 Patients with nonalcoholic fatty liver disease
- •4 Patients who have at least one of the following risks of heart failure: Established cardiovascular disease, LV hypertrophy, LA enlargement and E/e' > 9
- •5 Patients with HbA1c 10% or less
- •6 Patients with written informed consent
排除标准
- •1 eGFR < 45 ml/min/1.73 m2 at screening
- •2 Patients with chronic heart failure NYHA class II-IV and reduced ejection fraction (LVEF <= 40 %)
- •3 Patients with suspected severe liver fibrosis
- •4 Patients with acute myocardial infarction, ampulla cardiomyopathy and acute myocarditis in the prior 24 weeks
- •5 Patients who have underwent coronary revascularization by PCI or bypass surgery in the prior 8 weeks
- •6 Patients in whom coronary revascularization is being contemplated within 24 weeks
- •7 Diagnosed cardiac amyloidosis
- •8 Diagnosed persistent atrial fibrillation
- •9 Patients who have underwent valve replacement surgery, pacemaker implantation including cardiac resynchronization therapy or ICD implantation
- •10 Conditions preventing safe contrast-enhanced MRI imaging
- •11 Patients with contraindication to tofogliflozin
- •12 Patients treated with SGLT2 inhibitors within 12 weeks
- •13 Diagnosed idiopathic pulmonary fibrosis
- •14 Diagnosed malignant tumors
- •15 Female who are pregnant, breast-feeding, or may be pregnant
- •16 Subjects who have participated or plan to participate in another clinical research
- •17 Patients who were judged by the investigator to be inappropriate for the study
研究者
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