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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
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My doctor thinks I need and can handle treatment to remove a lot of fluid from my body.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Placebo
Ertugliflozin 5 mg + Sitagliptin 100 mg
Ertugliflozin 15 mg + Sitagliptin 100 mg

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
Ertugliflozin
2010
Completed Phase 3
~8940
Metolazone
2016
Completed Phase 4
~60

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,841 Previous Clinical Trials
2,734,467 Total Patients Enrolled
31 Trials studying Heart Failure
55,039 Patients Enrolled for Heart Failure
Merck Sharp & Dohme LLCIndustry Sponsor
3,868 Previous Clinical Trials
5,051,928 Total Patients Enrolled
24 Trials studying Heart Failure
20,209 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

Frequently Asked Questions

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

Are there any precedential experiments involving Ertugliflozin?

"Currently, there are 9 trials analyzing the efficacy of Ertugliflozin. 4 of those experiments have reached Phase 3. Although most studies take place in Cleveland Ohio, a total of 223 medical centres across the nation are performing research on this drug."

Answered by AI

Has a similar research endeavor been conducted prior to this?

"Ertugliflozin has been subjected to clinical testing since 2019 and the initial trial was sponsored by MSD Korea Ltd.. This drug received Phase 3 approval after a study of 120 patients, which is now followed up with 9 active trials taking place in 137 cities across 26 nations."

Answered by AI

What is the upper limit for enrollment in this clinical experiment?

"Affirmative. According to the data on clinicaltrials.gov, this medical trial is presently recruiting patients after being first published on March 10th 2021 and newly updated May 10th 2022. The investigation requires 90 participants from one center of care."

Answered by AI

Are there any safety risks associated with Ertugliflozin consumption?

"The safety of Ertugliflozin scored a 2 on our team's rating scale due to the presence of Phase 2 data that is suggestive of its security, but no evidence demonstrating therapeutic efficacy."

Answered by AI

Is enrolling now open for this clinical trial?

"Indeed, this clinical trial is still recruiting patients. It was initially made available to the public on March 10th 2021 and has had a few updates since then; most recently amended on May 10th 2022."

Answered by AI

To what end is Ertugliflozin frequently employed?

"Ertugliflozin is generally prescribed for hypertensive disease, but has been known to reduce swelling of the extremities and improve exercise tolerance in patients with congestive heart failure."

Answered by AI
~13 spots leftby Jan 2025