Empagliflozin in Acute Heart Failure (DRIP-AHF-1)

McGill University

Status and phase: Enrolling; Phase 4

Conditions: Chronic Kidney Diseases; Acute Heart Failure

Treatments: Drug: Empagliflozin 25 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT05305495

2022-8411

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Patients with diuretic resistance

Experimental group

Treatment:

Drug: Empagliflozin 25 MG