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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and one month
Awards & highlights

ERTU-SODIUM Trial 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.Check my eligibility
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.See study design
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.

ERTU-SODIUM Trial Eligibility Criteria

Inclusion Criteria

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

ERTU-SODIUM Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the skin water content
Secondary outcome measures
Change in interstitial Fluid
Change in left ventricular filling pressures
Change in plasma concentrations of aldosterone
+7 more

ERTU-SODIUM 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
858 Previous Clinical Trials
524,258 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
100 Total Patients Enrolled
1 Trials studying Heart Failure
100 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

Frequently Asked Questions

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

What is the projected participant count for this clinical experiment?

"Affirmative. As per the clinicaltrials.gov website, this medical investigation is currently recruiting patients and was initially posted on November 1st 2022. The most recent update occurred on November 3rd 2022, with 28 volunteers expected to be accepted from a single location."

Answered by AI

Is this medication compliant with the Food and Drug Administration's regulations?

"The safety of this treatment has been rated a 3, since it is in Phase 4 trials and thus approved."

Answered by AI

Are there still opportunities for new participants to join this research endeavor?

"Indeed, the information hosted on clinicaltrials.gov confirms that this medical research project is actively searching for participants. The trial was first listed on November 1st 2022 and has since been updated as of November 3rd 2022. 28 individuals have to be sourced from a single location"

Answered by AI

Are there any previous investigations related to this treatment?

"Currently, 8 clinical trials are underway to examine the efficacy of this medical treatment. Of those studies, 4 are in Phase 3 and 221 different sites across the United States offer access to these tests. The most concentrated region for such research is Cleveland, Ohio."

Answered by AI

Is this research project a groundbreaking discovery?

"Currently, 8 trials are ongoing involving the proposed medication. These clinical studies span 136 cities and 26 nations, with MSD Korea Ltd.'s 2019 Phase 3 drug approval trial being among the most noteworthy of these investigations having included 120 participants. In total, 18351 experiments have been conducted since that time."

Answered by AI
~10 spots leftby Dec 2024