Pioglitazone, Lipotoxicity, and Heart Failure With Preserved Ejection Fraction (HFpEF)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Our goal of the study is to learn the effects of the diabetes medication named Pioglitazone, in type-2 diabetic obese participants with Heart failure. The main question it aims to answer are: 1. To demonstrate that impaired mitochondrial function leading to reduced ATP generation plays a key pathophysiologic role in the development of heart failure with preserved ejection fraction (HFpEF) in obese type 2 diabetic (T2D) individuals. 2. To demonstrate that pioglitazone, improves diastolic (as well as systolic) function by improving myocardial insulin sensitivity and by reducing both myocardial and epicardial fat content.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 70
Healthy Volunteers: t
View:

• Provision of signed and dated informed consent form

• Stated willingness to comply with all study procedures and availability for the duration of the study

• Male or female, aged 30-70 years

• Body Mass Index (BMI) of 27.5-40kg/m²

• HbA1c of 6.5 to 10%

• Blood pressure of less than or equal to 145/65mmHg

• eGFR greater than 45 ml/min/1.73m²

• Subject must have HFpEF (EF \> 50% by ECHO screening)

• NYHA class II-III heart failure

⁃ Only T2D patients treated with diet/exercise, metformin, sulfonylurea, metformin/SU, DPP4i or insulin will be studied.

⁃ 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.

⁃ For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.

Locations
United States
Texas
Texas Diabetes Institute/UH
RECRUITING
San Antonio
Contact Information
Primary
Sivaram Neppala, MD
neppalas@uthscsa.edu
210-358-7200
Backup
Andrea Hansis-Diarte, MPH
Hansisdiarte@uthscsa.edu
210-567-3208
Time Frame
Start Date: 2023-07-10
Estimated Completion Date: 2030-01
Participants
Target number of participants: 78
Treatments
Active_comparator: Pioglitazone Administration Group
Pioglitazone 15mg/day titrated to 30 mg/day at week 2 and to 45 mg/day at week 4
Placebo_comparator: Placebo/Control Group
Placebo
Sponsors
Leads: The University of Texas Health Science Center at San Antonio

This content was sourced from clinicaltrials.gov