Pioglitazone on Heart Failure in Type-2 Diabetes Mellitus Participants

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO · Apr 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a diabetes medication called Pioglitazone to see how it affects people with both type 2 diabetes and heart failure. Specifically, the researchers want to understand if Pioglitazone can help improve heart function in obese individuals who have heart failure with preserved ejection fraction (HFpEF). This type of heart failure means the heart pumps normally, but it struggles to fill properly. The study will look at how Pioglitazone may improve the heart's ability to relax and fill with blood, which could benefit patients' overall heart health.

To participate in this trial, individuals must be between 30 and 70 years old, have a body mass index (BMI) between 27.5 and 40, and have type 2 diabetes managed by diet or certain medications. They also need to have a specific type of heart failure and meet certain health criteria, such as having controlled blood pressure and kidney function. Participants can expect to receive careful monitoring throughout the study, and they will need to follow specific guidelines regarding contraception if they are of reproductive age. This trial is currently recruiting, so those who meet the eligibility criteria and are interested can inquire about joining.

Gender

ALL

Eligibility criteria

• 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