Empagliflozin in Acute Heart Failure

Launched by MCGILL UNIVERSITY HEALTH CENTRE/RESEARCH INSTITUTE OF THE MCGILL UNIVERSITY HEALTH CENTRE · Mar 29, 2022

Keywords

ClinConnect Summary

This clinical trial, called "Empagliflozin in Acute Heart Failure," is exploring whether a medication called empagliflozin can help improve fluid removal in patients with acute heart failure who are also having trouble with their current diuretic treatment. Diuretics, such as furosemide, are often used to help patients eliminate excess fluid from their bodies, but some patients do not respond well to them. The researchers believe that adding empagliflozin to their treatment may enhance the effectiveness of furosemide, making it easier for these patients to manage their symptoms.

To be eligible for this study, participants need to have moderate to advanced chronic kidney disease and be experiencing acute heart failure symptoms, such as difficulty breathing, along with signs of fluid overload. They should also have shown poor response to diuretics, meaning they haven’t been able to eliminate enough fluid. Participants will be closely monitored throughout the trial and may experience improved fluid management as a result of the new treatment approach. It’s important to note that certain health conditions, like severe liver disease or recent use of specific medications, may prevent someone from joining the study.

Gender

ALL

Eligibility 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.