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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 up to day 84
Awards & highlights

EMPA HF Trial Summary

This trial is testing whether a diabetes medication can help improve heart function in patients with or without diabetes. 60 patients will be given the medication or a placebo for 6 weeks, then the placebo group will be given the medication for 6-12 weeks.

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.Check my eligibility
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.See study design
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.

EMPA HF Trial 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 heart failure symptoms are getting worse despite current treatments.
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My kidney function, measured by eGFR, is at least 20.
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I speak English.

EMPA HF Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

EMPA HF 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
2017
Completed Phase 3
~570
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,843 Previous Clinical Trials
2,735,177 Total Patients Enrolled
31 Trials studying Heart Failure
55,039 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available in this research project?

"Regrettably, the trial is not currently enrolling patients according to clinicaltrials.gov; this research was initially posted on November 1st 2022 and recently updated on September 21st 2022. However, there are 701 other studies actively recruiting participants at present."

Answered by AI

To what extent do the risks of Empagliflozin outweigh its benefits?

"The safety of Empagliflozin was rated at 1, due to it being in the early stages of clinical trials and having limited data regarding its efficacy."

Answered by AI

What is the desired outcome of this research endeavor?

"This clinical trial, which will be evaluated on Day 1 and its accompanying time frame, aims to measure the alteration in plasma volume from baseline at 7 days. Secondary objectives include assessing chronic empagliflozin vs placebo effects on change in plasma volume (using I-131 albumin) and total body water (utilizing heavy water [D2O]) during Days 1 & 42 as well as monitoring changes in total body water throughout an open label extension period between Day 1 & 84."

Answered by AI
~30 spots leftby Nov 2024