Acute Heart FailurePhase 4DRIP-AHF-1NCT05305495
Empagliflozin in Acute Heart Failure
A Phase 4 study testing Empagliflozin 25 MG in people with Acute Heart Failure and Chronic Kidney Diseases, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure, Chronic Kidney Diseases
- What is being tested?
- Empagliflozin 25 MG
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 22 Dec 2022to 10 Mar 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
Canada1 site
Research Institute of the McGill University Health Center
Montreal, Quebec
About this study
Official title: Empagliflozin for Patients With Acutely Decompensated Congestive Heart Failure, Diuretic Resistance, and Moderate to Advanced Chronic Kidney Disease
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
- Being tested
- Empagliflozin 25 MG
- Keywords
- Empagliflozin, Acute Heart Failure, Chronic kidney disease, Diuretic resistance, Furosemide
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 25 MGDrug
Also called Jardiance (DIN: 02443945)
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with diuretic resistance | Experimental | Not described Receives: Drug: Empagliflozin 25 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diuretic effect of empagliflozin in association with furosemide
Three-hour urine output post empagliflozin-furosemide administration, compared with furosemide alone
Measured: Day 1
Secondary outcomes (7)
Fractional excretion of sodium in the urine
FeNa (%)
Measured: Day 1
Total urine sodium output
Urine sodium per 24h
Measured: Day 1-5
Changes in volume status
Net fluid balance
Measured: Day 1-5
Incidence of AKI
Using the conventional KDIGO criteria
Measured: Day 1-5
Electrolyte abnormalities - Sodium
Concentration of sodium
Measured: Day 1-5
Electrolyte abnormalities - Potassium
Concentration of potassium
Measured: Day 1-5
Electrolyte abnormalities - Magnesium
Concentration of magnesium
Measured: Day 1-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start22 Dec 2022
- Primary completion15 Feb 2026
- Study completion10 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, interventional, single arm, cohort study
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Mavrakanas, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Thomas Mavrakanas, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305495
- Sponsor's protocol ID
- 2022-8411
- Acronym
- DRIP-AHF-1
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2022
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empagliflozin for Patients With Acutely Decompensated Congestive Heart Failure, Diuretic Resistance, and Moderate to Advanced Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT05305495
- Acronym / sponsor ID
- DRIP-AHF-1 / 2022-8411
- Conditions
- Acute Heart Failure, Chronic Kidney Diseases
- Keywords
- Empagliflozin, Acute Heart Failure, Chronic kidney disease, Diuretic resistance, Furosemide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 10 Mar 2026 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, interventional, single arm, cohort study
| Arm | Type | Receives |
|---|---|---|
| Patients with diuretic resistance | Experimental | Drug: Empagliflozin 25 MG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin 25 MGAlso: Jardiance (DIN: 02443945)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. | Drug | Patients with diuretic resistance |
Primary outcome
Diuretic effect of empagliflozin in association with furosemide
Time frame: Day 1
Three-hour urine output post empagliflozin-furosemide administration, compared with furosemide alone
7 secondary outcomes
Fractional excretion of sodium in the urine
Time frame: Day 1
Total urine sodium output
Time frame: Day 1-5
Changes in volume status
Time frame: Day 1-5
Incidence of AKI
Time frame: Day 1-5
Electrolyte abnormalities - Sodium
Time frame: Day 1-5
Electrolyte abnormalities - Potassium
Time frame: Day 1-5
Electrolyte abnormalities - Magnesium
Time frame: Day 1-5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Mavrakanas, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Empagliflozin 25 MG in people with Acute Heart Failure and Chronic Kidney Diseases, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diuretic effect of empagliflozin in association with furosemide (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.