Effect of Pioglitazone on Mitochondrial Metabolism in Pulmonary Hypertension Due to Chronic Lung Disease

STUDY00005871

The goal of this clinical trial is to learn about the safety and efficacy of Pioglitazone in people with Pulmonary Hypertension (PH) due to Chronic Lung Disease (CLD). The main question it aims to answer is: • Whether pioglitazone affects mitochondrial oxygen utilization in patients with PH due to CLD. Participants will be asked to take pioglitazone or placebo once daily for 28 days followed by a washout period of 2 weeks followed by 28 days of the other study drug (participants randomized to placebo followed by pioglitazone or pioglitazone followed by placebo).

2024-05-01

2028-08-01

2028-08-01

Not yet recruiting

Early phase I

20

Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures for the duration of the study * Confirmed to have pulmonary hypertension (PH) due to chronic lung disease at screening; Diagnosis must be confirmed by right heart catheterization. Right heart catheterization must be within 1 year of screening. * Ability to take oral medication and be willing to adhere to the study intervention regimen * For females of reproductive potential: agreement to use highly effective contraception 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 a partner * Agreement to adhere to Lifestyle Considerations (below) throughout the study duration o During this study, participants are asked to arrive in the clinic for study visits in the fasting state. Specifically, participants should abstain from any caloric intake for 6 hours prior to arrival for the study visit. Exclusion Criteria: * Diabetes mellitus (type 1 or type 2), present within the preceding 1 year * Personal history of symptomatic hypoglycemia within 90 days preceding enrollment * Personal outpatient use of pioglitazone, rosiglitazone, metformin, insulin, or other medications for the indication of diabetes within 90 days preceding enrollment * New York Heart Association Class III or IV symptoms due to heart failure at enrollment * History of prior or active bladder cancer * Thrombocytopenia (diagnosis or known platelet count ≤120) within 90 days preceding enrollment * Platelet count ≤120 during screening or on the day of enrollment hypertension due to chronic lung disease * Cystic fibrosis * Pregnancy or lactation * Current tobacco use * Known allergic reaction to components of the study medication (pioglitazone) * Treatment with another investigational drug within 30 days

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2024-04-01