Empagliflozin in Acute Heart Failure

NCT ID: NCT05305495

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-22
• Study Completion Date: 2027-02-28

Brief Summary

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.

Conditions

Acute Heart Failure; Chronic Kidney Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with diuretic resistance

Group Type: EXPERIMENTAL

Empagliflozin 25 MG

Intervention Type: 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.

Interventions

Empagliflozin 25 MG

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.

Intervention Type: DRUG

Other Intervention Names

Jardiance (DIN: 02443945)

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Thomas Mavrakanas

Assistant Professor, Junior Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Mavrakanas, MD

Role: PRINCIPAL_INVESTIGATOR

Research Institute of the McGill University Health Center

Locations

Research Institute of the McGill University Health Center

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Facility Contacts

Pedro Marques

Role: primary

pedro.marques@mail.mcgill.ca

5149341934

Other Identifiers

2022-8411

Identifier Type: -

Identifier Source: org_study_id