Diabetes drug pioglitazone tested for heart failure with preserved ejection fraction

NCT ID NCT05838287

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 22, 2026 · Last updated Sep 23, 2026 · Updated 1 time

Summary

Researchers are studying whether pioglitazone, a diabetes medication, can improve heart function in obese adults with type 2 diabetes and heart failure with preserved ejection fraction. The trial enrolls 78 participants aged 30 to 70 who take pioglitazone or a placebo for 24 weeks. Using cardiac MRI, the team measures changes in the heart's pumping and filling ability, along with heart fat content and insulin sensitivity.

What this could mean

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

Active substance
pioglitazone
What this could lead to
If pioglitazone helps, it could offer a new way to treat heart failure with preserved ejection fraction in people with type 2 diabetes and obesity.
What could go wrong
This is a small, single-center study. Pioglitazone can cause fluid retention and weight gain, which may worsen heart failure, so the risks need careful monitoring.

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

About 78 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Jan 2030

An estimate. End dates often move.

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

30 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 30-70 years 4. Body Mass Index (BMI) of 27.5-40kg/m² 5. HbA1c of 6.5 to 10% 6. Blood pressure of less than or equal to 145/65mmHg 7. eGFR greater than 45 ml/min/1.73m² 8. Subject must have HFpEF (EF \> 50% by ECHO screening) 9. NYHA class II-III heart failure 10. Only T2D patients treated with diet/exercise, metformin, sulfonylurea, metformin/SU, DPP4i or insulin will be studied. 11. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional \[4 weeks\] after the end of study participation. 12. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner. Exclusion Criteria: 1. Subjects with history of osteoporosis or proliferative diabetic retinopathy 2. Subjects with Heart failure due to restrictive or infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, severe valvular heart disease, etc. will be excluded 3. Patients with symptomatic coronary artery disease. 4. Subjects with significant change in diuretic management during the month prior to screening (defined by doubling of diuretic dose, or addition of another HF medication). 5. Subjects treated with a GLP-1 RA or thiazolidinedione. 6. Subjects treated with a SGLT2i 7. Pregnancy or lactation 8. Known allergic reactions to components of the study interventions. 9. Any metal plates, parts, screws, shrapnel, pins in body, or cardiac (heart) pacemaker

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Texas Diabetes Institute/UH

    RECRUITING

    San Antonio, Texas, 78229-3900, United States

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