2024-518591-31-00招募中2 期
SGLT2 INHIBITION (DAPAGLIFLOZIN) IN DIABETIC AND NON-DIABETIC HEMODIALYSIS PATIENTS WITH AND WITHOUT RESIDUAL URINE VOLUME: A PROSPECTIVE RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED PHASE II TRIAL
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 9
- 主要终点
- change in Left Ventricular Mass indexed to body surface area (LVMI [g/m²]) from baseline to 6 months
研究概览
简要总结
Comparing Cardiovascular Outcome between SGLT2i and Placebo
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Maintenance hemodialysis 3×/week for ≥ 3 months and ≤5 years
- •BMI < 45 kg/m2 and stable weight (± 5 kg) over the preceding three months
- •Signed informed consent
排除标准
- •o Hypersensitivity or Intolerance of SGLT2 inhibitors
- •o Other significant disease or pathology, that might predispose that patient to an unacceptable risk or interferes with the study in the opinion of the investigator.
- •o Acute coronary syndrome during the last 30 days
- •o SGLT2i within the last 6 months
- •o Child bearing potential & unwilling / unable to use an acceptable method to avoid pregnancy for the entire study (estrogen and/or progesterone treatment).
- •o Pregnancy
- •o Breast feeding
- •o Participation in another clinical trial
- •o History of diabetic ketoacidosis
- •o Life expectancy < 1 year
- •o Interventricular septum width ≤ 11 mm
- •o Severe valvular heart disease
- •o Substance abuse
- •o History of Type 1 diabetes mellitus
- •o Scheduled kidney transplant from a living donor
结局指标
主要结局
change in Left Ventricular Mass indexed to body surface area (LVMI [g/m²]) from baseline to 6 months
change in Left Ventricular Mass indexed to body surface area (LVMI [g/m²]) from baseline to 6 months
次要结局
- Glucose Insulin C-Peptide Glucagon Glucagon-like Peptide-1 Epinephrine Norepinephrine Cortisol Growth Hormone Lactate Alanine β-hydroxybutyrate (βOHB) HbA1C Left Ventricular Mass (LVM) Left Ventricular Ejection Fraction (EF), Left Ventricular Hypertrophy (LVH) cardiac fibrosis Left Ventricular Mass Index to height(LVMI [m²]) Left Atrial Diameter (LAD [mm]) Blood Pressure (mmHg) Body Weight BMI Predialysis TnT postdialysis TnT proBNP Quality of Life
研究者
Department of Medicine III Division of Nephrology and Dialysis
Scientific
Medical University Of Vienna
研究点 (9)
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