Empagliflozin in Acute Heart Failure

Phase 4

Recruiting

• Conditions: Acute Heart Failure; Chronic Kidney Diseases
• Interventions: Drug: Empagliflozin 25 MG

• Registration Number: NCT05305495
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary

The objective is to study in a prospective, interventional, single arm, cohort study the potential synergistic diuretic effect of empagliflozin, in addition to furosemide, in hypervolemic patients admitted with acutely decompensated heart failure and diuretic resistance at the McGill University Health Centre (MUHC).

The investigators hypothesize that the sodium-glucose cotransporter-2 (SGLT-2) inhibitor empagliflozin will enhance the diuretic effect of furosemide in patients with acutely decompensated heart failure, moderate to advanced chronic kidney disease, and underlying diuretic resistance, as identified by the three-hour urine output post diuretic administration on the first day of the study, compared with furosemide alone.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-04
• Study First Submitted QC: 2022-03-29
• Study First Posted: 2022-03-31
• Study Start: 2022-12-22
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-08
• Primary Completion: 2026-12
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

• new use of a non-loop diuretic other than an MRA
• history of type 1 diabetes mellitus
• euglycemic diabetic ketoacidosis
• liver disease defined by serum levels of transaminases or alkaline phosphatase more than three times the upper limit of normal at screening
• known hypersensitivity to SGLT-2 inhibitors
• use within the last 48 h of an SGLT-2 inhibitor or a combined SGLT-1 and SGLT-2 inhibitor
• maintenance dialysis or need for emergent renal replacement therapy
• gastrointestinal surgery or gastrointestinal disorder that could interfere with trial medication absorption
• recurrent severe genital or urinary tract infection
• pregnancy or breastfeeding
• any other clinical condition that would jeopardize patient safety while participating in this trial
• Patients with an acute rise in creatinine levels (acute cardiorenal syndrome) upon presentation will not be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with diuretic resistance	Empagliflozin 25 MG	-

Primary Outcome Measures

Name	Time	Method
Diuretic effect of empagliflozin in association with furosemide	Day 1	Three-hour urine output post empagliflozin-furosemide administration, compared with furosemide alone

Secondary Outcome Measures

Name	Time	Method
Fractional excretion of sodium in the urine	Day 1	FeNa (%)
Total urine sodium output	Day 1-5	Urine sodium per 24h
Electrolyte abnormalities - Sodium	Day 1-5	Concentration of sodium
Electrolyte abnormalities - Potassium	Day 1-5	Concentration of potassium
Changes in volume status	Day 1-5	Net fluid balance
Incidence of AKI	Day 1-5	Using the conventional KDIGO criteria
Electrolyte abnormalities - Magnesium	Day 1-5	Concentration of magnesium

Trial Locations

Locations (1)

Research Institute of the McGill University Health Center; 🇨🇦 Montreal, Quebec, Canada