Diabetes drug pioglitazone tested for heart failure with preserved ejection fraction
NCT ID NCT05838287
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 78 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2023
- Expected to finish
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Jan 2030
An estimate. End dates often move.
- Lead sponsor
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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
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30 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Texas Diabetes Institute/UH
RECRUITINGSan Antonio, Texas, 78229-3900, United States
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