EUCTR2016-003743-10-DK进行中（未招募）1 期
Effects of SGLT-2 Inhibitor on Myocardial Perfusion, Function and Metabolism in Type 2 DM Patients at high cardiovascular risk: The SIMPle Randomized Clinical Trial - SIMPle
Herlev og Gentofte Hospital0 个研究点目标入组 92 人开始时间: 2016年10月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 92
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •T2 DM (WHO criteria), diagnosed at least 3 months prior to visit 0
- •Patients with diabetes must be either untreated or treated with one or more oral anti-diabetic drugs, including incretin therapy, GLP-1 analogues or treated with human NPH-insulin or long-acting insulin analogue, alone or in combination with oral drugs
- •For patients on background therapy: stable dose of anti-diabetics within 30 days prior to baseline
- •HbA1c of = 48 mmol/L and = 86 mmol/L at screening for patients on background therapy or HbA1c of = 48 mmol/L and = 75 mmol/L at screening for drug-naïve patients.
- •BMI = 45 kg/m2 at screening
- •Age =18 years
- •Negative pregnancy test (fertile women). Fertile women must use safe contraceptives (spiral, hormonal contraceptives) for the duration of the study
- •Able to understand the written patient information and to give informed consent
- •Patients must have high cardiovascular risk, defined as at least one of the following:
- •Albuminuria ( albumin/creatinine ratio = 30 mg/g or plasma NT-proBNP = 70 pg/ml)
- •Confirmed history of myocardial infarction (>2 months prior to baseline)
- •Heart failure according to Framingham Heart Failure Criteria
- •Patient discharged from hospital with a documented diagnosis of unstable angina within 12 months prior to baseline
- •Evidence of coronary artery disease by CAG in 1 or more major coronary arteries
- •A positive noninvasive stress test, or a positive stress echocardiography showing regional systolic wall motion abnormalities, or a positive scintigraphic test showing stress-induced ischemia,
- •History of ischemic or haemorrhagic stroke (>2 months prior to informed consent)
- •Presence of peripheral artery disease (symptomatic or not ) documented by either: previous limb angioplasty, stenting or bypass surgery; or previous limb or foot amputation due to circulatory insufficiency; or angiographic evidence of significant (> 50%) peripheral artery stenosis in at least one limb; or evidence from a non-invasive measurement of significant (>50% or as reported as hemodynamically significant) peripheral artery stenosis in at least one limb; or ankle brachial index of < 0.9
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 62
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Allergic to the study medication
- •Treatment with SGLT-2 inhibitor within 1 months prior to baseline
- •Impaired kidney function, eGFR = 30 ml/min
- •Severe liver insufficiency (Child-Pugh class C)
- •ECG showing malign ventricular arrhythmia or prolonged QT-interval (>500ms)
- •Untreated clinical significant heart valve disease
- •Planned cardiac surgery or angioplasty within 3 months.
- •Myocardial infarction (MI) = 30 days prior to baseline
- •Percutaneous coronary intervention (PCI) = 4 weeks prior to baseline
- •History of coronary artery bypass graft (CABG) = 8 weeks prior to enrollment
- •Prior history of heart transplantation
- •Unstable angina, known severe left main coronary artery stenosis, severe heart failure, uncontrolled arrhythmias, symptomatic hypotension or severe hypertension (systolic blood pressure < 90 or > 180 mmHg, respectively), sick sinus syndrome or > 1st degree atrioventricular block in the absence of a functioning pacemaker
- •Requirement of emergent cardiac medical intervention or catheterization
- •Treatment with theophylline, or theophylline containing medications
- •History of known or suspected bronchoconstrictive or bronchospastic lung disease (e.g., asthma)
- •Pregnancy or desire hereof or breastfeeding.
研究者
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