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Heart failure drug may ease tissue congestion without harming blood flow

NCT ID NCT05152940

Disease control Sponsor: Icahn School of Medicine at Mount Sinai Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether the diabetes drug ertugliflozin can reduce fluid buildup in the skin and tissues of people with heart failure. 28 adults with reduced heart function took the drug or a placebo for one month each. Researchers measured skin water and sodium content to see if the drug relieves congestion better than placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ertugliflozin
What this could lead to
If successful, this could show that ertugliflozin relieves tissue congestion in heart failure without affecting blood volume, potentially improving symptoms.
What could go wrong
This is a small, early-phase study with only 28 participants, so results may not apply broadly. The drug may not show a clear benefit over placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

28 people

The number who actually took part.

Started

Feb 2023

Finished

Oct 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * age \>18 years; * males and females (females of child bearing potential must be using adequate contraceptive precautions) * diagnosis of heart failure (New York Heart Association \[NYHA\] functional class II to III); * Left ventricular ejection fraction \<40%; * stable symptoms and medical therapy within the last month. * Informed consent has to be given in written form Exclusion criteria: * taking SGLT2i in the last month * acute coronary syndrome or cardiac surgery within the last month; * estimated glomerular filtration rate \<20 ml/kg/min; * use of continuous parental inotropic agents; * systolic blood pressure \<90 mm Hg; * LVAD implantation or cardiac transplantation * pregnant or lactating women; and * any other medical condition considered unappropriated by a study physician

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Conditions

The condition(s) this trial relates to.

heart failure systolic heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Congestion Heart failure with reduced ejection fraction

Contacts and locations

Locations

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.