SGLT2 Inhibition in Hemodialysis (DAPA-HD)

Medical University of Vienna

Status and phase: Active, not recruiting; Phase 2

Conditions: Chronic Kidney Disease; Kidney Failure; Hemodialysis; Left Ventricular Hypertrophy; Diabetes Mellitus, Type 2

Treatments: Drug: Dapagliflozin 10 MG; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05179668

EK-Nr.: 1196/2021

2021-000733-14 (EudraCT Number)

Details and patient eligibility

About

Dapagliflozin will be compared with placebo to evaluate its effects on cardiac structure and safety in patients with kidney failure receiving maintenance hemodialysis.

Full description

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.

Enrollment: 220 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• Substance abuse
• Life expectancy < 1 year
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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220 participants in 2 patient groups, including a placebo group

Dapagliflozin 10 mg

Experimental group

Treatment:

Drug: Dapagliflozin 10 MG

Placebo tablet

Placebo Comparator group

Treatment:

Drug: Placebo