JPRN-jRCTs051210084招募中4 期
Efficacy of Tofogliflozin on Left Ventricular Diastolic Dysfunction in Patients with Heart Failure with Preserved Ejection Fraction and Type 2 Diabetes Mellitus - TOP-HFPEF
Kitakaze Masafumi0 个研究点目标入组 90 人开始时间: 2021年9月16日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
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 <= 90age old（—）
- 性别
- All
入选标准
- •1) 20-90 years of age at the time of consent
- •2) Type 2 diabetic patients who meet either criteria below
- •1. Patients necessary to start or change the treatment using anti-diabetic agent(s)
- •2. Patients under the treatment of anti-diabetic agent(s) and may change the medication
- •3) Patients who have diagnosed as heart failure
- •Patients who satisfy any of the following conditions within 26 weeks before the time of consent are considered as heart failure
- •1. NYHA functional classification II, III or IV
- •2. BNP or NT-proBNP levels of the following (if there were two or more measurements, enroll when it met the criteria once)
- •a) Patients with sinus rhythm: BNP >=40pg/mL or NT-proBNP >=125pg/mL
- •b) Patients with atrial fibrillation: BNP >=60pg/mL or NT-proBNP >=190pg/mL
- •3. Patients with a history of heart failure and require medical therapy
- •4) Patients with LV ejection fraction (LVEF) >=50% within 39 weeks before the time of consent (if there were two or more measurements, enroll when the latest measurement was LVEF >=50%)
- •5) Patients who have provided written informed consent
排除标准
- •1) Patients with severe renal failure (eGFR <30mL/min/1.73m2) or end-stage renal disease on dialysis
- •2) Patients with HbA1c >=12% at the time of consent
- •3) Patients whose BMI was less than 18.5kg/m2 at the time of consent
- •4) Patients with contraindications to tofogliflozin (e.g. hypersensitivity, severe ketosis, diabetic coma/precoma, severe infection, perioperative, severe trauma)
- •5) Patients with medical history of SGLT2 inhibitor
- •6) Patients with history of stroke or transient ischemic attack within 13 weeks before the time of consent
- •7) Patients with history of acute coronary syndrome, myocarditis or takotsubo cardiomyopathy within 26 weeks before the time of consent
- •8) Patients who have taken or scheduled to take any of the treatment listed below within 6 months before the time of consent:
- •1. Coronary artery bypass grafting or percutaneous coronary intervention
- •2. Pacemaker implantation
- •3. Cardiac resynchronization therapy
- •4. Cardiac surgery (including catheter treatment)
- •5. Catheter ablation for atrial fibrillation/ atrial flutter/ atrial tachycardia
- •9) Patients who are assumed to have left ventricular diastolic failure due to hypertrophic cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis
- •10) Patients with cardiac symptom of NYHA functional class IV at the time of consent
- •11) Patients with hepatic dysfunction with AST or ALT 3-fold of upper limit of normal at the time of consent (if increased AST of ALT is determined to be attributable to cardiac diseases, patients do not meet this exclusion criterion as long as total bilirubin levels are <3.0mg/dL)
- •12) Patients who are pregnant, breastfeeding, or possibly pregnant at the time of consent
- •13) Patients who have been enrolled or planning to participate in other interventional clinical studies during the course of this study
- •14) Patients who are judged by the investigator or subinvestigators to be inappropriate for this study
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