Using empagliflozin to improve diuretic response in acute heart failure patients
Empagliflozin for Patients With Acutely Decompensated Congestive Heart Failure, Diuretic Resistance, and Moderate to Advanced Chronic Kidney Disease
This study is testing if adding empagliflozin to the usual diuretic treatment can help people with acute heart failure and kidney issues produce more urine.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT05305495 on ClinicalTrials.gov |
What this trial studies
This study investigates the potential benefits of adding empagliflozin, a sodium-glucose cotransporter-2 (SGLT-2) inhibitor, to the standard treatment of furosemide in patients with acute heart failure and diuretic resistance. It is a prospective, interventional, single-arm cohort study conducted at the McGill University Health Centre. The primary focus is on patients with moderate to advanced chronic kidney disease who are experiencing inadequate diuretic response. The study aims to measure the diuretic effect by comparing urine output after administering both medications.
Who should consider this trial
Good fit: Ideal candidates include patients with acute heart failure, moderate to advanced chronic kidney disease, and evidence of diuretic resistance.
Not a fit: Patients with stable heart failure who do not exhibit diuretic resistance or those with mild chronic kidney disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance diuretic efficacy and improve fluid management in patients with acute heart failure and chronic kidney disease.
How similar studies have performed: Other studies have shown promising results with SGLT-2 inhibitors in heart failure management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Montreal, Quebec
- Research Institute of the McGill University Health Center — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Thomas Mavrakanas, MD — Research Institute of the McGill University Health Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.