Can a diabetes pill help heart failure patients get rid of excess fluid?
NCT ID NCT05305495
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether adding empagliflozin (a diabetes drug) to standard diuretics helps hospitalized heart failure patients with moderate to advanced kidney disease urinate more fluid. 25 participants were given the combination, and researchers measured urine output. The goal was to see if this approach could overcome diuretic resistance and improve fluid removal.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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25 people
The number who actually took part.
- Started
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Dec 2022
- Finished
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Mar 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria (all have to apply) : * 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. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Research Institute of the McGill University Health Center
Montreal, Quebec, Canada
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