NCT06336798 · Emory University
Bioenergetic Effect of Pioglitazone in CLD-PH
What this study is about
The goal of this clinical trial is to learn about the safety and effectiveness 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.
View original scientific description
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).
Interventions
DRUG
Pioglitazone 30mg
Study participants will take Pioglitazone 30 mg PO daily
DRUG
Placebo
Study participants will take a placebo PO daily
DIAGNOSTIC_TEST
Labs
Labs will be performed for Urine HCG, Complete Blood count (CBC), Chemistry Panel, Fasting lipids, insulin, glucose, and Bioenergetic analysis (platelets).
Primary outcome measures
Change in Mitochondrial metabolism parameters: Spare respiratory capacity
Time frame: Day 1, Day 28, Day 70
Mitochondrial metabolism is measured using a research protocol employing the Agilent Seahorse extracellular flux bioanalyzer. Standard Seahorse assay protocols have been adapted for use with human platelets . Spare respiratory capacity (SRC) is calculated by (maximal respiration) - (basal respiration) during the mitochondrial stress test. The value is reported in pmol/min.
Change in Mitochondrial metabolism parameters: Maximal respiration
Time frame: Day 1, Day 28, Day 70
Maximal Respiration is calculated by: (post-carbonyl cyanide 4-(trifluoromethoxy) phenylhydrazone(FCCP) - (nonmitochondrial respiration) during the mitochondrial stress test. The value is reported in pmol/min.
Change in Mitochondrial metabolism parameters: Basal respiration
Time frame: Day 1, Day 28, Day 70
Basal respiration is calculated by (Baseline) - (nonmitochondrial respiration) ) during the mitochondrial stress test. The value is reported in pmol/min.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Atlanta, Georgia
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 3, 2025 · Source of record for eligibility and locations