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SGLT2 Inhibitor

Ertugliflozin for Heart Failure (ERTU-SODIUM Trial)

Phase 4
Recruiting
Led By Carlos G Santos-Gallego, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of heart failure (New York Heart Association [NYHA] functional class II to III)
Age >18 years
Must not have
Use of continuous parental inotropic agents
Estimated glomerular filtration rate <20 ml/kg/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and one month
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial tests whether or not Ertugliflozin can help relieve congestion in the legs and improve blood flow.

Who is the study for?
This trial is for adults over 18 with heart failure (NYHA class II to III) and a left ventricular ejection fraction below 40%. Participants must have stable symptoms, not used SGLT2 inhibitors recently, and have normal kidney function. Women of childbearing age should use contraception; pregnant or breastfeeding women can't join.
What is being tested?
The study tests Ertugliflozin's effect on body fluid distribution in heart failure patients. It aims to see if the drug can reduce tissue congestion by removing excess sodium and water from the skin without affecting blood volume significantly compared to a placebo.
What are the potential side effects?
Potential side effects of Ertugliflozin may include dehydration due to increased urination, low blood pressure, dizziness, yeast infections due to sugar in urine, urinary tract infections, and possible changes in kidney function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have heart failure and experience mild to moderate symptoms.
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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am on continuous heart-strengthening medications through an IV.
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My kidney function is very low.
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I have had a heart transplant or a device implanted to help my heart pump.
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I have had a heart attack or heart surgery in the last month.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and one month
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and one month 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 in the skin water content
Secondary study objectives
Change in interstitial Fluid
Change in left ventricular filling pressures
Change in plasma concentrations of aldosterone
+7 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Active Control
Group I: Ertugliflozin then PlaceboActive Control2 Interventions
Treatment with Ertugliflozin for one month, washout period for one month, and then with Placebo for one month
Group II: PlaceboActive Control2 Interventions
Treatment with matching placebo for one month, washout period for one month, and then Ertugliflozin for one month

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
904 Previous Clinical Trials
541,793 Total Patients Enrolled
12 Trials studying Heart Failure
2,312 Patients Enrolled for Heart Failure
Carlos G Santos-Gallego, MDPrincipal InvestigatorIcanh School of Medicine at Mount Sinai
1 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Heart Failure
60 Patients Enrolled for Heart Failure

Media Library

Ertugliflozin (SGLT2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05152940 — Phase 4
Heart Failure Research Study Groups: Ertugliflozin then Placebo, Placebo
Heart Failure Clinical Trial 2023: Ertugliflozin Highlights & Side Effects. Trial Name: NCT05152940 — Phase 4
Ertugliflozin (SGLT2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05152940 — Phase 4
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