Effects of Pioglitazone on Pulmonary Hypertension from Lung Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety and efficacy of Pioglitazone in patients suffering from Pulmonary Hypertension (PH) due to Chronic Lung Disease (CLD). Participants will be randomly assigned to receive either Pioglitazone or a placebo for 28 days, followed by a washout period and then switched to the other treatment for another 28 days. The primary focus is to determine how Pioglitazone affects mitochondrial oxygen utilization in these patients, addressing a potential metabolic pathway involved in PH. The study aims to provide insights into a novel therapeutic approach for a condition that significantly impacts patient quality of life.

Why it matters

Who can join: the full rules

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 it's running

• Emory Healthcare System
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: Aaron Trammell — Emory University
• Study coordinator: Aaron Trammell, MD, MSc
• Email: awtramm@emory.edu
• Phone: 404-712-8204

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.