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NCT05305495CompletedPhase 4

Empagliflozin in Acute Heart Failure

Empagliflozin for Patients With Acutely Decompensated Congestive Heart Failure, Diuretic Resistance, and Moderate to Advanced Chronic Kidney Disease

Source: ClinicalTrials.gov · Last updated 16 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
25 (actual)
First submitted
4 Mar 2022
Start date
22 Dec 2022
Primary completion date
15 Feb 2026
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
NCT number
NCT05305495

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 25
  • From 22 Dec 2022 to the primary completion date, 15 Feb 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • history of type 1 diabetes mellitus
  • known hypersensitivity to SGLT-2 inhibitors
  • gastrointestinal surgery or gastrointestinal disorder that could interfere with trial medication absorption
  • recurrent severe genital or urinary tract infection
  • any other clinical condition that would jeopardize patient safety while participating in this trial

Lab values

  • liver disease defined by serum levels of transaminases or alkaline phosphatase more than three times the upper limit of normal at screening
  • Patients with an acute rise in creatinine levels (acute cardiorenal syndrome) upon presentation will not be excluded.

Other

  • new use of a non-loop diuretic other than an MRA
  • euglycemic diabetic ketoacidosis
  • pregnancy or breastfeeding

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Research Institute of the McGill University Health Center
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.