Hepato-renal Regulation of Water Conservation in Heart Failure Patients With SGLT-2 Inhibitor Treatment

Sponsor
National Heart Centre Singapore
Study ID
NCT04080518
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10 MG [Forxiga] — DRUG
    24 Hour Urine Collection, Sodium (23Na) MRI and Magnetic Resonance (MR) spectroscopy scan, Blood collection for metabolomic and osmolyte analysis

Study Details

The purpose of this study is to investigate the effects of Dapagliflozin (FORXIGA) 10mg (n=20) and placebo (n=20) on the renal concentration mechanism, mobilization of Na+ from tissue stores, and mobilization of muscle glycogen and fat, in patients heart failure NYHA classes I and II,with or w/o T2DM in a 4-week double-blind, placebo-controlled, randomized study with 2 treatment arms.

Key Dates

Start date
Nov 11, 2019
Status verified
Apr 2023
Primary completion
Nov 10, 2021
Completion
Nov 10, 2021

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Experimental
    Dapagliflozin, 10mg, oral dose, once every day
  • Placebo Comparator: Control
    Matching placebo for dapagliflozin, oral dose, once every day

Primary Outcome Measure

To demonstrate that SGLT-2 inhibition induces urea-dominated renal water conservation within the renal concentration mechanism. ( Change from baseline in urinary osmolyte concentration [ Time Frame: Baseline, Day 3, and Day 28. ]

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