Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04764097
Status:
WITHDRAWN
Last Update Posted:
2021-10-21
First Post:
2021-02-18
Brief Title:
Dapagliflozin Effect on Cardiovascular Outcomes in Haemodialysis for End Stage Renal Disease
Sponsor:
Tan Tock Seng Hospital
Organization:
Tan Tock Seng Hospital
Study Overview
Official Title:
A Multi-centre Randomised Double-blind Placebo-controlled Trial to Determine the Effect of Dapagliflozin 10mg Once Daily on Cardiovascular Outcomes in Haemodialysis for Patients With End Stage Renal Disease ESRD
Status:
WITHDRAWN
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of funding and similar competing study being conducted in Europe
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DECODED
Brief Summary:
This study aims to study SGLT2 inhibitors in patients who are undergoing haemodialysis for end stage renal disease and established ASCVD to examine the safety and clinical outcomes consisting of a composite of non-fatal stroke non-fatal myocardial infarction or cardiovascular death as the primary outcome The key secondary composite outcome was all cause death or hospitalization for unstable angina
Detailed Description:
Cardiovascular disease accounts for more than 50 of end-stage renal disease ESRD deaths The reported cardiovascular death rates in patients receiving dialysis are substantially higher than in the general population Cardiovascular mortality in ESRD is particularly high after acute myocardial infarction but it is also elevated in ESRD patients with other forms of atherosclerotic vascular disease eg chronic coronary artery disease strokes transient ischemic attacks and peripheral arterial disease Left ventricular hypertrophy and dilation are associated with increased cardiovascular mortality as is congestive heart failure One of the major reasons for such high cardiovascular mortality in ESRD is the large burden of cardiovascular disease present in patients with chronic artery disease before renal replacement therapy
SGLT2 inhibitors have demonstrated benefits in reduction of major adverse cardiac events and heart failure hospitalisation in phase 3 randomised controlled trials In addition several recent clinical publications have also indicated renal benefits in patients with chronic renal impairment eGFR 30mlmin
The primary SGLT2 inhibition predominantly occurs at the proximal tubules of kidneys The mechanistic benefits postulated other than serum glucose lowering included SGL2i mediated naturesis and glucosuria Independent of this classs effects at the renal level SGL2i possibly affect cardiac metabolism in animal studies with reverse adverse cardiac remodelling by switching myocardial substrate utilization from glucose toward oxidation of fatty acids ketone bodies and branch-chained amino acids Such improvement in cardiac metabolism may attenuate myocardial ischemia improve cardiac haemodynamics and reduce overall cardiac mortality either independent of or synergistic with SGLT2 inhibition at the kidney level
Currently there is a gap in knowledge and paucity of safety efficacy and clinical outcomes data for the use of SGLT2 inhibitors in patients who are undergoing haemodialysis for end stage renal disease and established ASCVD
This study aims to study SGLT2 inhibitors in this population and examine the safety and clinical outcomes consisting of a composite of non-fatal stroke non-fatal myocardial infarction or cardiovascular death as the primary outcome The key secondary composite outcome was all cause death or hospitalization for unstable angina
SGLT2 inhibitors have demonstrated benefits in reduction of major adverse cardiac events and heart failure hospitalisation in phase 3 randomised controlled trials In addition several recent clinical publications have also indicated renal benefits in patients with chronic renal impairment eGFR 30mlmin
The primary SGLT2 inhibition predominantly occurs at the proximal tubules of kidneys The mechanistic benefits postulated other than serum glucose lowering included SGL2i mediated naturesis and glucosuria Independent of this classs effects at the renal level SGL2i possibly affect cardiac metabolism in animal studies with reverse adverse cardiac remodelling by switching myocardial substrate utilization from glucose toward oxidation of fatty acids ketone bodies and branch-chained amino acids Such improvement in cardiac metabolism may attenuate myocardial ischemia improve cardiac haemodynamics and reduce overall cardiac mortality either independent of or synergistic with SGLT2 inhibition at the kidney level
Currently there is a gap in knowledge and paucity of safety efficacy and clinical outcomes data for the use of SGLT2 inhibitors in patients who are undergoing haemodialysis for end stage renal disease and established ASCVD
This study aims to study SGLT2 inhibitors in this population and examine the safety and clinical outcomes consisting of a composite of non-fatal stroke non-fatal myocardial infarction or cardiovascular death as the primary outcome The key secondary composite outcome was all cause death or hospitalization for unstable angina
Study Oversight
Has Oversight DMC:
None
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?:
None