Effect of Pioglitazone on Mitochondrial Metabolism in Pulmonary Hypertension Due to Chronic Lung Disease
Emory University
Summary
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).
Description
Pulmonary hypertension (PH) is a state of chronic elevated pressure in the pulmonary circulation. PH has multiple possible causes, clinically classified into 5 separate groups according to the World Symposium on PH classification scheme. PH is common in adults, with increasing prevalence with age, and is associated with significant symptom burden and mortality. In the U.S., approximately 1.5 million U.S. adults have PH, including 5-10% of people \>65. Metabolic abnormalities have been highlighted recently as contributing to PH pathogenesis, disease severity, and outcome. In pre-clinical studi…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 disease…
Interventions
- DrugPioglitazone 30mg
Study participants will take Pioglitazone 30 mg PO daily
- DrugPlacebo
Study participants will take a placebo PO daily
- Diagnostic TestLabs
Labs will be performed for Urine HCG, Complete Blood count (CBC), Chemistry Panel, Fasting lipids, insulin, glucose, and Bioenergetic analysis (platelets).
Location
- Emory Healthcare SystemAtlanta, Georgia