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Sodium-glucose cotransporter 2 (SGLT2) inhibitor

Empagliflozin for Heart Failure (EMPA HF Trial)

Phase 1
Recruiting
Led By Jeffrey Testani, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years old
A planned outpatient diuretic intervention (either up-titration of loop or addition of thiazide diuretic) for worsening heart failure per treating clinician. Diuretic intervention can occur via an unplanned in person visit (e.g., outpatient ambulatory clinic, emergency department, same day access visit) or via a telephone encounter (e.g., patient calling the clinic with reported weight gain and SOB that is prescribed uptitration of diuretic therapy)
Must not have
Anemia with hemoglobin <8g/dL (due to required phlebotomy for the study) or active bleeding
Critical stenotic valvular disease, complex congenital heart disease or prior heart transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 up to day 84

Summary

This trial tests empagliflozin in patients with worsening heart failure to see if it can help by removing extra sugar and salt from their bodies. The study includes patients with or without diabetes. Empagliflozin has been shown to reduce mortality and hospitalization for heart failure in diabetic patients.

Who is the study for?
Adults over 18 with worsening heart failure, who've gained at least 5 lbs due to this condition and are on a stable dose of diuretics can join. They must have an eGFR ≥ 20 mL/min/1.73 m2 and be able to follow the study's procedures. Excluded are those with severe anemia, urinary issues, certain heart conditions, pregnant or breastfeeding women, or those needing hospitalization for heart failure.
What is being tested?
The trial is testing Empagliflozin (a diabetes medication) in patients with worsening heart failure regardless of their diabetes status. Participants will either receive Empagliflozin or a placebo for six weeks; then those on placebo will switch to the active drug for another six weeks.
What are the potential side effects?
Empagliflozin may cause urinary tract infections, changes in urination frequency, low blood sugar levels (in diabetic patients), possible dehydration due to increased urination and rare cases of serious bacterial infections if one has a history of such conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My doctor plans to adjust my water pill treatment for worsening heart failure.
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I have been taking a water pill daily for at least a month.
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I have gained at least 5 lbs recently.
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My kidney function, measured by eGFR, is at least 20.
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I speak English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have anemia with hemoglobin below 8g/dL or I am currently bleeding.
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I have a serious heart valve problem, complex heart condition from birth, or had a heart transplant.
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I have a history of severe diabetes issues, including emergency treatments in the last 6 months.
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I regularly take high doses of water pills for my condition.
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I have major issues controlling my bladder.
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I need to be hospitalized for heart failure now.
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I am currently on or planning to start dialysis.
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I have had many urinary tract infections or a severe infection called urosepsis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 up to day 84
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to day 84 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Plasma Substitutes
Change in total body water from baseline to 7 days
Natriuretic effect of empagliflozin or placebo as an adjuvant to loop diuretic therapy
Secondary study objectives
Blood Plasma Volume
Change in Chronic effects of empagliflozin on change in total body water during the open label extension.
Change in Chronic effects of empagliflozin vs placebo on change in total body water
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo, Then EmpagliflozinExperimental Treatment2 Interventions
Participants first receive matching placebo daily for weeks 1-6, then will receive Empagliflozin 10 mg daily for weeks 7-12
Group II: EmpagliflozinExperimental Treatment1 Intervention
Empagliflozin 10 mg daily for weeks 1-6
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Empagliflozin 10 mg
2021
Completed Phase 4
~650
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,922 Previous Clinical Trials
3,031,482 Total Patients Enrolled
35 Trials studying Heart Failure
58,121 Patients Enrolled for Heart Failure
Jeffrey Testani, MDPrincipal InvestigatorYale University
6 Previous Clinical Trials
579 Total Patients Enrolled
3 Trials studying Heart Failure
529 Patients Enrolled for Heart Failure

Media Library

Empagliflozin (Sodium-glucose cotransporter 2 (SGLT2) inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05553938 — Phase 1
Heart Failure Research Study Groups: Empagliflozin, Placebo, Then Empagliflozin
Heart Failure Clinical Trial 2023: Empagliflozin Highlights & Side Effects. Trial Name: NCT05553938 — Phase 1
Empagliflozin (Sodium-glucose cotransporter 2 (SGLT2) inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05553938 — Phase 1
~27 spots leftby Nov 2025
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