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Heart failure drug shows promise for Non-Diabetic patients

NCT ID NCT05562063

Disease control Sponsor: Juan Badimon 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether the drug sotagliflozin can improve heart function in people with a type of heart failure called HFpEF who do not have diabetes. Eighty-eight participants took either the drug or a placebo for six months. Researchers used heart scans and exercise tests to measure changes in heart structure and function.

What this could mean

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

Active substance
Sotagliflozin
What this could lead to
If successful, this could point toward a new treatment option for heart failure patients without diabetes, potentially improving heart function and quality of life.
What could go wrong
This is a small, early-phase trial with only 88 participants, so results may not apply to everyone. The drug may not show significant benefits, and side effects are possible.

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

88 people

The number who actually took part.

Started

Oct 2022

Finished

Jun 2025

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: patients should meet all of the following criteria * Ambulatory patients age ≥ 18 years * Written informed consent prior to admission to the trial. * No diabetes as confirmed by HbA1c \<6.5%, fasting serum glucose \<126 mg/dL, and review of concomitant medications and medical history * Diagnosis of Heart failure (NYHA II to III) * LVEF \> 50% * On medical therapy for heart failure consistent with prevailing cardiovascular guidelines at a stable dose for ≥4 weeks prior to screening, except for diuretics which must have been stable for ≥2 weeks prior to screening * Women of child-bearing potential must agree to use birth control measures with a failure rate of \<1% per year during the treatment period of the study Exclusion Criteria: * Type 1 and Type 2 diabetes * Acute coronary syndrome (ACS) or cardiac surgery within the last week. * Pregnant or lactating women, * Acute decompensated HF or hospitalized for HF within 1 month from screening visit * Glomerular Filtration Rate (GFR) \< 25 ml/ min/1.73m2, * Patients on drugs with potential interaction with sotagliflozin including digoxin, phenytoin, HIV medication and rifampin. * Receiving SGLT2-I 3-months prior to randomization. * non-MRI compatible PM or ICD and any other medical or physical condition considered unappropriated by a study physician.

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Conditions

The condition(s) this trial relates to.

diastolic heart failure

As listed by the trial registrant

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

Heart failure with preserved 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.