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Pioglitazone for Pulmonary Hypertension Due to Chronic Lung Disease

This study is investigating if Pioglitazone 30mg can help people with pulmonary hypertension (high blood pressure in the lungs) caused by chronic lung disease. Researchers want to see if Pioglitazone affects how cells use oxygen, specifically looking at mitochondrial metabolism (how cells create energy). You would take either Pioglitazone or a placebo (an inactive pill) daily for 28 days, followed by a break, and then switch to the other treatment for another 28 days. The study will measure changes in your mitochondrial metabolism at different time points to see if Pioglitazone is effective. To join, you must be 18 or older and have confirmed pulmonary hypertension due to chronic lung disease. The study plans to enroll 20 participants, but its current recruitment status is unclear.

Study design
This is an interventional study where participants will be randomized to receive either Pioglitazone or a placebo, then switch treatments after a break. It aims to enroll 20 participants.
What's involved
You would take a study drug (Pioglitazone or placebo) daily for 28 days, have a 2-week break, then take the other study drug for another 28 days. You will also have blood and urine tests performed at Day 1, Day 28, and Day 70.
Compensation
Not stated in the trial record.
Follow-up
Your mitochondrial metabolism will be measured at Day 1, Day 28, and Day 70 to track changes.

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NCT06336798

Bioenergetic Effect of Pioglitazone in CLD-PH

Recruiting
PHASE2Ages 18+InterventionalTreatment
Emory University
~20 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:Pioglitazone 30mgPlaceboLabs

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Mitochondrial metabolism parameters: Spare respiratory capacity
Measured over Day 1, Day 28, Day 70
+2 more outcomes measured

Conditions

Pulmonary Hypertension
Pulmonary Hypertension Due to Lung Diseases

Explore related trials

Pulmonary Hypertension

Where it's being run

1 sites across 1 states
Georgia1

Study leadership

  • Aaron Trammell · PRINCIPAL_INVESTIGATOR · Emory University

Who to contact

Aaron Trammell, MD, MSc
[email protected]
404-712-8204
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in Mitochondrial metabolism parameters: Spare respiratory capacityDay 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 respirationDay 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 respirationDay 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.