Bioenergetic Effect of Pioglitazone in CLD-PH

Launched by EMORY UNIVERSITY · Mar 22, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the use of a medication called pioglitazone in people who have pulmonary hypertension (PH) caused by chronic lung diseases. The main goal is to see if pioglitazone can help improve how the body uses oxygen at the cellular level in these patients. During the study, participants will take either pioglitazone or a placebo (a look-alike pill with no active medication) once a day for 28 days. After a short break, they will switch to the other pill for another 28 days.

To be eligible for the trial, participants should be between 65 and 74 years old, have confirmed pulmonary hypertension due to chronic lung disease, and be willing to follow the study's guidelines. This includes taking oral medications and fasting before clinic visits. Certain medical conditions, like diabetes or a history of heart failure, may exclude someone from participating. If you or a loved one are interested in joining, it’s a great opportunity to contribute to important research that may help improve treatments for pulmonary hypertension.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Provision of a 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
• * Pulmonary hypertension is defined based on meeting all three of the following measured at rest during the RHC:
• • Mean pulmonary artery pressure \>20 mmHg
• • Pulmonary artery wedge pressure ≤15 mmHg
• • Pulmonary vascular resistance \> 2 Wood units
• • Pulmonary hypertension is classified in Group 3: PH associated with lung diseases and/or hypoxia
• • Medications approved for the treatment of pulmonary hypertension must be at a stable dose for at least 30 days
• • 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 before 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
• • History of left ventricular failure (systolic or diastolic)
• • Pulmonary hypertension due to Group 2 PH (PH due to left heart disease)
• • 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