Empagliflozin for Patients With Acutely Decompensated Congestive Heart Failure, Diuretic Resistance, and Moderate to Advanced Chronic Kidney Disease

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
Research Institute of the McGill University Health Center
RECRUITING
Montreal
Time Frame
Start Date: 2022-12-22
Estimated Completion Date: 2027-02
Participants
Target number of participants: 25
Treatments
Experimental: Patients with diuretic resistance
Related Therapeutic Areas
Sponsors
Leads: McGill University Health Centre/Research Institute of the McGill University Health Centre

This content was sourced from clinicaltrials.gov