Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
Study NCT ID:
NCT05179668
Status:
UNKNOWN
Last Update Posted:
2022-10-25
First Post:
2021-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SGLT2 Inhibition in Hemodialysis
Sponsor:
Medical University of Vienna
Organization:
Study Overview
Official Title:
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
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DAPA-HD
Brief Summary:
The study is designed as a prospective randomized, controlled, double-blinded phase II trial to examine the effect of the SGLT2 inhibitor dapagliflozin, in comparison with placebo on cardiovascular outcome parameters in kidney failure patients undergoing replacement therapy with hemodialysis.
The primary endpoint is the change (∆) in left ventricular mass indexed to body surface area (LVMi) from baseline to 6 months measured by cardiac magnetic resonance imaging.
Null and alternative hypotheses:
H0: There is no difference in the ∆ Left Ventricular Mass indexed to BSA after six months of treatment, comparing patients having received the SGLT2-Inhibitor Dapagliflozin versus placebo.
H1: There is a difference in the ∆ Left Ventricular Mass indexed to BSA comparing patients having received the SGLT2-Inhibitor Dapagliflozin versus placebo.
The primary endpoint is the change (∆) in left ventricular mass indexed to body surface area (LVMi) from baseline to 6 months measured by cardiac magnetic resonance imaging.
Null and alternative hypotheses:
H0: There is no difference in the ∆ Left Ventricular Mass indexed to BSA after six months of treatment, comparing patients having received the SGLT2-Inhibitor Dapagliflozin versus placebo.
H1: There is a difference in the ∆ Left Ventricular Mass indexed to BSA comparing patients having received the SGLT2-Inhibitor Dapagliflozin versus placebo.
Detailed Description:
The parallel groups will receive dapagliflozin 10 mg vs. placebo (1:1 manner; n = 54 per group) for 6 months. Cardiological outcome parameters will include the change in left ventricular mass (LVM), left ventricular ejection fraction (EF), cardiac fibrosis and left atrial diameter (LAD) from baseline to 6 months measured by cMRI and strain echocardiography.
Biochemical data will be collected prior to hemodialysis at baseline and periodically (e.g. blood gas analysis at every dialysis visit, measurements of and pre- and post- dialysis troponin T (TnT) and pro brain natriuretic peptide (proBNP) every 4 weeks).
A full laboratory analysis of blood cell count, blood coagulation and clinical chemistry will be performed at baseline, 3 months, and 6 months. Additionally, body weight will be measured at all study visits to monitor changes after SGLT2 inhibitor administration. Hospitalizations and mortality will be monitored clinically.
Further secondary endpoints are glucometabolic parameters (HbA1c, plasma values of insulin, c-peptide, glucagon, glucagon-Like peptide-1 (GLP1), cortisol, growth hormone, alanine, β-hydroxybutyrate (βOHB) \[=ketone\] and pyruvate concentration) and will be determined at baseline, 3 and 6 months. The HOMA-Indices will be calculated with the values of insulin and fasting glucose for monitoring of diabetes performed at baseline, 3 months, and 6 months.
Volume status and fluid composition will be measured by bioimpedance spectroscopy at the baseline, 3 months, and end-of-study-visit. In case of hypervolemia, ultrafiltration parameters will be adapted to reach a dry weight based in synopsis of clinical status and body composition monitoring results.
In terms of urinary output and tubuloglomerular feedback, a stratification by residual urine volume by 200 mL per day will be performed to elucidate study aim IV. Prior results of diabetes independent renal and cardiovascular benefit legitimate an examination of groups with and without prevalent diabetes mellitus.
Biochemical data will be collected prior to hemodialysis at baseline and periodically (e.g. blood gas analysis at every dialysis visit, measurements of and pre- and post- dialysis troponin T (TnT) and pro brain natriuretic peptide (proBNP) every 4 weeks).
A full laboratory analysis of blood cell count, blood coagulation and clinical chemistry will be performed at baseline, 3 months, and 6 months. Additionally, body weight will be measured at all study visits to monitor changes after SGLT2 inhibitor administration. Hospitalizations and mortality will be monitored clinically.
Further secondary endpoints are glucometabolic parameters (HbA1c, plasma values of insulin, c-peptide, glucagon, glucagon-Like peptide-1 (GLP1), cortisol, growth hormone, alanine, β-hydroxybutyrate (βOHB) \[=ketone\] and pyruvate concentration) and will be determined at baseline, 3 and 6 months. The HOMA-Indices will be calculated with the values of insulin and fasting glucose for monitoring of diabetes performed at baseline, 3 months, and 6 months.
Volume status and fluid composition will be measured by bioimpedance spectroscopy at the baseline, 3 months, and end-of-study-visit. In case of hypervolemia, ultrafiltration parameters will be adapted to reach a dry weight based in synopsis of clinical status and body composition monitoring results.
In terms of urinary output and tubuloglomerular feedback, a stratification by residual urine volume by 200 mL per day will be performed to elucidate study aim IV. Prior results of diabetes independent renal and cardiovascular benefit legitimate an examination of groups with and without prevalent diabetes mellitus.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2021-000733-14 | EUDRACT_NUMBER | None | View |