SGLT2 lnhibition in Hemodialysis (DAPA-HD)

Phase 2

Not yet recruiting

• Conditions: Chronic Kidney Disease; Kidney Failure; Left Ventricular Hypertrophy; Hemodialysis

• Registration Number: 2024-518591-31-00
• Lead Sponsor: Medical University Of Vienna

Brief Summary

Comparing Cardiovascular Outcome between SGLT2i and Placebo

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-12-15
• Last Update Posted: 2024-12-15

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 220

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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		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

Trial Locations

Locations (9)

Klinik Donaustadt; 🇦🇹 Vienna, Austria

Klinik Hietzing; 🇦🇹 Vienna, Austria

Wiener Dialysezentrum GmbH; 🇦🇹 Vienna, Austria

Dialyseinstitut Dr. Waller; 🇦🇹 Feldbach, Austria

Klinik Landstrabe; 🇦🇹 Vienna, Austria

Klinik Favoriten; 🇦🇹 Vienna, Austria

Dialyseinstitut Gießauf GmbH; 🇦🇹 Graz, Austria

Hanusch Krankenhaus Der Wiener Gebietskrankenkasse; 🇦🇹 Vienna, Austria

Medical University Of Vienna; 🇦🇹 Vienna, Austria

Klinik Donaustadt

🇦🇹Vienna, Austria

Renate Klauser-Braun

Site contact

+431288025400

renate.klauser-braun@gesundheitsverbund.at