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Empagliflozin for Acute Heart Failure (DRIP-AHF-1 Trial)
Phase 4
Recruiting
Led By Thomas Mavrakanas, MD
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1-5
Awards & highlights
DRIP-AHF-1 Trial Summary
This trial will study the potential benefits of adding the drug empagliflozin to furosemide for people with acutely decompensated heart failure, moderate to advanced chronic kidney disease, and underlying diuretic resistance.
Who is the study for?
This trial is for adults with acute heart failure and moderate to advanced chronic kidney disease who are not responding well to diuretics. They must have stable blood pressure, no severe liver disease, no history of type 1 diabetes or recent use of SGLT-2 inhibitors, and not be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study tests if empagliflozin can boost the water-pill effect of furosemide in patients with heart failure who don't pee enough after taking diuretics. It's a single-group study where all participants get both drugs at McGill University Health Centre.See study design
What are the potential side effects?
Empagliflozin may cause urinary tract infections, changes in urination, low blood sugar levels (especially if diabetic), dehydration leading to low blood pressure, ketoacidosis even without high sugar levels (a serious condition where the body produces excess acid), and genital infections.
DRIP-AHF-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My body didn't respond well to water pills, showing little urine output or weight loss.
Select...
I have severe heart failure with symptoms at rest and signs of fluid buildup.
Select...
My kidney function is moderately to severely reduced.
DRIP-AHF-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1-5
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1-5
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Diuretic effect of empagliflozin in association with furosemide
Secondary outcome measures
Changes in volume status
Electrolyte abnormalities - Magnesium
Electrolyte abnormalities - Potassium
+4 moreSide effects data
From 2023 Phase 1 & 2 trial • 29 Patients • NCT0490721417%
Skin infection
17%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Empagliflozin
DRIP-AHF-1 Trial Design
1Treatment groups
Experimental Treatment
Group I: Patients with diuretic resistanceExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Empagliflozin
FDA approved
Find a Location
Who is running the clinical trial?
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
437 Previous Clinical Trials
158,998 Total Patients Enrolled
5 Trials studying Heart Failure
387 Patients Enrolled for Heart Failure
Thomas Mavrakanas, MDPrincipal InvestigatorResearch Institute of the McGill University Health Center
2 Previous Clinical Trials
136 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with type 1 diabetes.Criterion: Experiencing a type of diabetic ketoacidosis with normal blood sugar levels.I have no GI surgeries or disorders affecting medication absorption.I am starting a new diuretic medication that is not a loop diuretic or an MRA.My body didn't respond well to water pills, showing little urine output or weight loss.I have severe heart failure with symptoms at rest and signs of fluid buildup.I am on regular dialysis or might need emergency kidney treatment.My liver tests are more than three times the normal limit.My kidney function has recently worsened, but I can still participate.I frequently have severe infections in my genital or urinary areas.You are allergic to SGLT-2 inhibitors.I have taken an SGLT-2 inhibitor in the last 2 days.Your blood pressure has been steady without needing certain medications for the past day.My kidney function is moderately to severely reduced.
Research Study Groups:
This trial has the following groups:- Group 1: Patients with diuretic resistance
Awards:
This trial has 5 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still space available for participants to join this research trial?
"The details on clinicaltrials.gov show that this medical trial, which was posted December 1 2022 and last updated September 5th 2022, is not currently recruiting patients; however, 1181 other trials are actively seeking out participants."
Answered by AI
To what extent could Empagliflozin 25 MG be detrimental to human health?
"As this is a Phase 4 clinical trial, there is extensive evidence that Empagliflozin 25 MG has been deemed safe for general use and thus received a score of 3 on our scale."
Answered by AI
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