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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with diuretic resistance | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Diuretic effect of empagliflozin in association with furosemide | Three-hour urine output post empagliflozin-furosemide administration, compared with furosemide alone | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Fractional excretion of sodium in the urine | FeNa (%) | Day 1 |
| Total urine sodium output | Urine sodium per 24h | Day 1-5 |
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Inclusion Criteria (all have to apply) :
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Mavrakanas, MD | Research Institute of the McGill University Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Institute of the McGill University Health Center | Montreal | Quebec | Canada |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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Prospective, interventional, single arm, cohort study
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|
|
| Changes in volume status | Net fluid balance | Day 1-5 |
| Incidence of AKI | Using the conventional KDIGO criteria | Day 1-5 |
| Electrolyte abnormalities - Sodium | Concentration of sodium | Day 1-5 |
| Electrolyte abnormalities - Potassium | Concentration of potassium | Day 1-5 |
| Electrolyte abnormalities - Magnesium | Concentration of magnesium | Day 1-5 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |