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
概览
- 阶段
- 2 期
- 干预措施
- Dapagliflozin 10 MG
- 疾病 / 适应症
- Kidney Failure
- 发起方
- Medical University of Vienna
- 入组人数
- 220
- 试验地点
- 9
- 主要终点
- Change in left ventricular mass indexed to body surface area
- 状态
- 已完成
- 最后更新
- 2个月前
概览
简要总结
Dapagliflozin will be compared with placebo to evaluate its effects on cardiac structure and safety in patients with kidney failure receiving maintenance hemodialysis.
详细描述
The Dapagliflozin in Hemodialysis (DAPA-HD) trial is an academic, multicenter, randomized, double-blind, placebo-controlled phase 2 study designed to assess the cardiovascular effects of dapagliflozin in patients with kidney failure undergoing maintenance hemodialysis. A total of 220 patients are randomized 1:1 to dapagliflozin 10 mg once daily or matching placebo for six months, with stratification according to residual urine output. The primary endpoint is the change in left ventricular mass indexed to body surface area, assessed by transthoracic echocardiography after six months of treatment. Secondary endpoints include additional echocardiographic measures, biomarker changes, quality of life, clinical events, and safety outcomes.
研究者
Assoc. Prof. Dr. Manfred Hecking, MD PhD
Principal Investigator
Medical University of Vienna
入排标准
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 \["dry weight"\]) over the preceding three months
- •Interventricular septum width \>11 mm
排除标准
- •Treatment with SGLT2i within the last 6 months
- •Hypersensitivity or Intolerance of SGLT2 inhibitors
- •History of Type 1 diabetes mellitus
- •History of diabetic ketoacidosis
- •Scheduled kidney transplant from a living donor
- •Acute coronary syndrome during the last 30 days
- •Severe valvular heart disease
- •Women of childbearing potential and unwilling or unable to use an acceptable method to avoid pregnancy for the entire study (estrogen and/or progesterone treatment).
- •Pregnancy
- •Breast feeding
研究组 & 干预措施
Dapagliflozin 10 mg
干预措施: Dapagliflozin 10 MG
Placebo tablet
干预措施: Placebo
结局指标
主要结局
Change in left ventricular mass indexed to body surface area
时间窗: 6 months
Change in left ventricular mass indexed to body surface area using echocardiography
次要结局
- Change in LVEF assessed by echocardiography(6 months)
- Change in in LA volume index assessed by echocardiography(6 months)
- Change in left ventricular mass indexed to body height assessed by echocardiography(6 months)
- Change in in GLS assessed by echocardiography(6 months)
- Change in in Cardiac Biomarkers (NT-proBNP, hsTnT)(6 months)
- Change in health-related quality of life(6 months)
- Change in LV end-diastolic volume assessed by echocardiography(6 months)
- Change in LV end-systolic volume assessed by echocardiography(6 months)
- Change in body weight(6 months)
- Change in blood pressure(6 months)