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

Primary Purpose

Acute Heart Failure, Chronic Kidney Diseases

Status

Recruiting

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Empagliflozin 25 MG

About this trial

This is an interventional treatment trial for Acute Heart Failure focused on measuring Empagliflozin, Acute Heart Failure, Chronic kidney disease, Diuretic resistance, Furosemide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Research Institute of the McGill University Health CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with diuretic resistance

Arm Description

Outcomes

Primary Outcome Measures

Diuretic effect of empagliflozin in association with furosemide

Three-hour urine output post empagliflozin-furosemide administration, compared with furosemide alone

Secondary Outcome Measures

Fractional excretion of sodium in the urine

FeNa (%)

Total urine sodium output

Urine sodium per 24h

Changes in volume status

Net fluid balance

Incidence of AKI

Using the conventional KDIGO criteria

Electrolyte abnormalities - Sodium

Concentration of sodium

Electrolyte abnormalities - Potassium

Concentration of potassium

Electrolyte abnormalities - Magnesium

Concentration of magnesium

Full Information

NCT ID

NCT05305495

First Posted

March 4, 2022

Last Updated

January 3, 2023

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT05305495

Brief Title

Empagliflozin in Acute Heart Failure

Acronym

DRIP-AHF-1

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 22, 2022 (Actual)

Primary Completion Date

August 2024 (Anticipated)

Study Completion Date

July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Heart Failure, Chronic Kidney Diseases

Keywords

Empagliflozin, Acute Heart Failure, Chronic kidney disease, Diuretic resistance, Furosemide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Model Description

Prospective, interventional, single arm, cohort study

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients with diuretic resistance

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Empagliflozin 25 MG

Other Intervention Name(s)

Jardiance (DIN: 02443945)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Diuretic effect of empagliflozin in association with furosemide

Description

Three-hour urine output post empagliflozin-furosemide administration, compared with furosemide alone

Time Frame

Day 1

Secondary Outcome Measure Information:

Title

Fractional excretion of sodium in the urine

Description

FeNa (%)

Time Frame

Day 1

Title

Total urine sodium output

Description

Urine sodium per 24h

Time Frame

Day 1-5

Title

Changes in volume status

Description

Net fluid balance

Time Frame

Day 1-5

Title

Incidence of AKI

Description

Using the conventional KDIGO criteria

Time Frame

Day 1-5

Title

Electrolyte abnormalities - Sodium

Description

Concentration of sodium

Time Frame

Day 1-5

Title

Electrolyte abnormalities - Potassium

Description

Concentration of potassium

Time Frame

Day 1-5

Title

Electrolyte abnormalities - Magnesium

Description

Concentration of magnesium

Time Frame

Day 1-5

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Mavrakanas, MD

Organizational Affiliation

Research Institute of the McGill University Health Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Institute of the McGill University Health Center

City

Montreal

State/Province

Quebec

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pedro Marques

Phone

5149341934

pedro.marques@mail.mcgill.ca

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Empagliflozin in Acute Heart Failure

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