JPRN-jRCTs041210022招募中未知
Tofogliflozin mechanism of Action to Retain cardiac function evaluated by (123)I-MIBG scintigraphy, Echocardiography and biomarkers in T2DM patients with Heart Failure - TARGET-HF
Murohara Toyoaki0 个研究点目标入组 50 人开始时间: 2021年5月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 50
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 ot applicable（—）
- 性别
- All
入选标准
- •1.Aged >=20 years
- •2.Diagnosis of type 2 diabetes mellitus and HbA1c of >= 6.5% and =< 10.0%* within 12 weeks before informed consent
- •*If taking medication for type 2 diabetes since before informed consent,patients whose research physicians determined needed additional type 2 diabetes mellitus drugs were not affected by HbA1c levels.
- •3.Established documented diagnosis of chronic heart failure NYHA class 2 or 3, for at least 8 weeks prior to informed consent
- •4.LVEF < 40% within 12 weeks prior to informed consent
- •5.Sinus rhythm and NT-proBNP >= 125 pg/mL or patients with atrial fibrillation and NT-proBNP >= 365 pg/mL within 12 weeks prior to informed consent
- •6.eGFR >= 30mL/min/1.73m^2 within 12 weeks prior to informedconsent
- •7.Signed and dated informed consent
排除标准
- •1.Receiving therapy with a SGLT2 inhibitor within 8 weeks prior to informed consent
- •2.Receiving therapy with an insulin within 8 weeks prior to informed consent
- •3.Change in drugs or dosage within 4 weeks prior to informed consent
- •4.Sympomatic hypotension or systolic blood pressure < 95mmHg
- •5.History of hospitalization for acute heart failure or heart failure within 4 weeks prior to informed consent
- •6.History of myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks prior to informed consent
- •7.History of PCI, CABG, valvular repair/replacement within 12 weeks prior to informed consent or with plans
- •8.History of Pacemaker implantation within 12 weeks prior to informed consent or plans
- •9.Previous cardiac transplantation or with plans
- •10.Restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic cardiomyopathy or valvular disease
- •11.Symptomatic bradycardia
- •12.Known hypersensitivity to iodine hypersensitivity
- •13.Receiving therapy with Reserpine,Tricyclic Antidepressants,labetalol
- •14.Parkinsons disease
- •15.Malignant tumor in need of treatment
- •16.Indication of liver disease, defined by serum levels of either ALT, AST above 3 times upper limit of normal, or total bilirubin above 2 times upper limit of normal
- •17.Severe impaired renal function, defined as eGFR < 30 mL/min/1.73m^2
- •18.BMI < 18.5 kg/m^2
- •19.Breastfeeding, pregnant or intent to be pregnant
- •20.Severe ketosis, diabetic coma or precoma
- •21.Severe infection, preioperative or serious trauma
- •22.Known hypersensitivity to tofogliflozin
- •23.Inappropriate condition for this clinical trial based on the investigators clinical judgement
研究者
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