Empagliflozin in Acute Heart Failure

NCT05305495 | Completed Phase 4

• 1 other identifier: 2022-8411
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Heart Failure; Chronic Kidney Diseases

Keywords

Empagliflozin; Acute Heart Failure; Chronic kidney disease; Diuretic resistance; Furosemide

Outcome Measures

Primary Outcomes (1)

• Diuretic effect of empagliflozin in association with furosemide

  Three-hour urine output post empagliflozin-furosemide administration, compared with furosemide alone

  Day 1

Secondary Outcomes (7)

• Fractional excretion of sodium in the urine

  Day 1

• Total urine sodium output

  Day 1-5

• Changes in volume status

  Day 1-5

• Incidence of AKI

  Day 1-5

• Electrolyte abnormalities - Sodium

  Day 1-5

Study Arms (1)

Patients with diuretic resistance

EXPERIMENTAL

Drug: Empagliflozin 25 MG

Interventions

Empagliflozin 25 MG DRUG

Patients who fulfill the inclusion criteria will receive an intravenous dose of 1.0-1.5 mg/kg of furosemide (≤120 mg) and urine output will be monitored for three hours. Those with a urine output \< 300 ml in the first two hours post furosemide administration will receive a single oral dose of 25 mg of empagliflozin. Two hours after taking empagliflozin, patients will receive a second intravenous dose of 1.0-1.5 mg/kg of furosemide with another timed urine collection at three hours. Empagliflozin will then be continued daily for five days or until hospital discharge, unless the treating physician considers this not to be clinically appropriate.

Also known as: Jardiance (DIN: 02443945)

Patients with diuretic resistance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• moderate to advanced CKD, defined as an eGFR \<45 ml/min/1.73m2; The average creatinine values over the last 12 months will be used to calculate baseline eGFR.
• acutely decompensated heart failure, defined as dyspnea at rest or with minimal physical activity, associated with at least one clinical sign of congestion and at least one objective measure of heart failure (pulmonary-capillary wedge pressure \>20 mm Hg or evidence of pulmonary congestion on chest radiography or brain natriuretic peptide (BNP) level ≥400 pg/ml or N-terminal pro-BNP level ≥1000 pg/ml);
• evidence of inadequate response to loop diuretics, defined as a urine output \< 1000 ml/24h or a weight loss \< 1kg /24h. For patients who have not received loop diuretics, a furosemide stress test can be conducted.
• stable hemodynamics, defined as systolic blood pressure \>90 mmHg and/or mean arterial pressure \>65 mmHg in the absence of intravenous norepinephrine or epinephrine in the last 24 hours.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Research Institute of the McGill University Health Center

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Mavrakanas, MD

  Research Institute of the McGill University Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Junior Scientist

Model Details: Prospective, interventional, single arm, cohort study

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 31, 2022
• Study Start: December 22, 2022
• Primary Completion: February 15, 2026
• Study Completion: March 10, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)