Effects of Pioglitazone on Pulmonary Hypertension from Lung Disease
Effect of Pioglitazone on Mitochondrial Metabolism in Pulmonary Hypertension Due to Chronic Lung Disease
This study is testing if the medication Pioglitazone can help people with pulmonary hypertension caused by chronic lung disease feel better and improve their oxygen use.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT06336798 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with pulmonary hypertension due to chronic lung disease who meet specific hemodynamic criteria.
Not a fit: Patients with pulmonary hypertension not associated with chronic lung disease or those who cannot comply with study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new treatment option that improves outcomes for patients with pulmonary hypertension due to chronic lung disease.
How similar studies have performed: While clinical trials targeting PPARγ activation in pulmonary hypertension have not been previously conducted, the approach is considered promising based on pre-clinical findings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Atlanta, Georgia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.