Bioenergetic Effect of Pioglitazone in CLD-PH
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Pulmonary Hypertension, Pulmonary Hypertension Due to Lung Diseases
In brief
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).
Key facts
- Study ID
- NCT06336798
- Run by
- Emory University
- People needed
- 20
- Starts
- 2024-12-17
- Expected to finish
- 2028-02-01
- Last updated by the study team
- 2026-07-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Emory Healthcare System — Atlanta, Georgia, United States (enrolling)
Full record on ClinicalTrials.gov
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