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SGLT2 Inhibitor

Ertugliflozin for Heart Failure

Phase 2
Recruiting
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Chronic daily oral loop diuretic dose > or equal to 20mg furosemide equivalents for at least one month prior to admission
A clinical diagnosis of ADHF with at least one objective sign of volume overload (rales, edema, elevated JVP, or preadmission weight gain)
Must not have
Prior heart transplant, critical stenotic valvular disease or complex congenital heart
Significant bladder dysfunction or urinary incontinence
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days

Summary

This trial will test whether adding ertugliflozin, metolazone or placebo to intravenous loop diuretic use in acute settings and chronic oral loop diuretic therapy can improve heart failure signs and symptoms.

Who is the study for?
This trial is for adults with acute decompensated heart failure who have signs of fluid overload and need intravenous diuretics. They must be on a stable dose of oral loop diuretics, have an eGFR of at least 30 mL/min/1.73 m2, and can't be using thiazide or similar drugs. Excluded are those planning renal therapy, with significant bladder issues, history of certain diabetes complications, frequent urinary infections, severe anemia, or are pregnant/breastfeeding.
What is being tested?
The study tests the effects of Ertugliflozin versus Metolazone (a type of diuretic) or placebo in managing heart failure symptoms alongside standard IV loop diuretics. It aims to understand how Ertugliflozin affects cardio-renal factors differently from traditional diuretics without causing excessive fluid loss.
What are the potential side effects?
Potential side effects may include dehydration due to increased urination from the diuretic effect; low blood pressure; kidney function changes; electrolyte imbalances like low potassium or sodium levels; and possibly increased risk for urinary tract infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been taking a strong water pill daily for at least a month.
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I have been diagnosed with acute heart failure and show signs of fluid buildup.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a heart transplant or have serious heart valve disease.
Select...
I have major issues controlling my bladder.
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I have had many UTIs or a severe infection in my urinary tract.
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My hemoglobin level is below 8g/dL.
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I am currently using or plan to start kidney replacement therapy this hospital stay.
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I have a history of severe diabetes issues in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline to 6 weeks total body water by add-on to loop diuretic therapy (Chronic)
Change from baseline to day 7 of total body water by add-on to loop diuretic therapy (Chronic)
Natriuretic effect of adjuvant to loop diuretic therapy

Side effects data

From 2016 Phase 3 trial • 291 Patients • NCT02226003
5%
Urinary tract infection
3%
Blood glucose increased
1%
Toxicity to various agents
1%
Spinal column stenosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ertugliflozin 5 mg + Sitagliptin 100 mg
Ertugliflozin 15 mg + Sitagliptin 100 mg
Placebo

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: MetolazoneExperimental Treatment1 Intervention
Participants will be randomized to six weeks of treatment with either ertugliflozin, metolazone, or a placebo
Group II: ErtugliflozinExperimental Treatment1 Intervention
Participants will be randomized to six weeks of treatment with either ertugliflozin, metolazone, or a placebo
Group III: PlaceboPlacebo Group1 Intervention
Participants will be randomized to six weeks of treatment with either ertugliflozin, metolazone, or a placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metolazone
2016
Completed Phase 4
~60
Ertugliflozin
2010
Completed Phase 3
~8940

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,924 Previous Clinical Trials
3,031,598 Total Patients Enrolled
35 Trials studying Heart Failure
58,121 Patients Enrolled for Heart Failure
Merck Sharp & Dohme LLCIndustry Sponsor
4,015 Previous Clinical Trials
5,186,273 Total Patients Enrolled
25 Trials studying Heart Failure
20,559 Patients Enrolled for Heart Failure

Media Library

Ertugliflozin (SGLT2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04438213 — Phase 2
Heart Failure Research Study Groups: Metolazone, Ertugliflozin, Placebo
Heart Failure Clinical Trial 2023: Ertugliflozin Highlights & Side Effects. Trial Name: NCT04438213 — Phase 2
Ertugliflozin (SGLT2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04438213 — Phase 2
~3 spots leftby Jan 2025
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