NCT03741972已完成不适用
Metabolic and Hemodynamic Effects of the Inhibitors of Type 2 Sodium Glucose Co-transporters (ISGLT2) in Diabetic Patients With Heart Failure. GLUCOSUR-IC Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in cardiac biomarkers
研究概览
简要总结
Inhibitors of the type 2 sodium-glucose co-transporter (iSGLT2) may improve the metabolic and hemodynamic profile in patients with DM2 and heart failure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Type 2 Diabetes
- •HbA1c> 6.5%
- •Estimated GF> 45 ml / min
- •BMI: ≥25 Kg / m2
- •Stable pharmacological treatment of Heart Failure in the last 3 months
排除标准
- •Diabetes type 1 or type LADA (presence of antibodies against GAD and/or IA-2 positive)
- •DM2 with C-peptide <1 ng / mL
- •GEF <45 ml / min
- •Recurrent urinary tract infections
研究组 & 干预措施
Treatment
Patients with diabetes and heart failure that are treated with iSGLT2
干预措施: iSGTL2 (Drug)
结局指标
主要结局
Change in cardiac biomarkers
时间窗: 12 months
Changes in cardiac biomarkers: NTproBNP, CA125 and ST2
次要结局
- Improvement of pulmonary congestion(12 months)
- Improve in the 6-minute walk(12 months)
- Change in quality of life: EuroQol-5D questionnaire (EuroQol five dimension questionnaire)(12 months)
研究者
Antoni Bayés Genís
Chief of the Cardiology Unit
Germans Trias i Pujol Hospital
研究点 (1)
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