Effect of Pioglitazone on Mitochondrial Metabolism in Pulmonary Hypertension Due to Chronic Lung Disease

Status: Recruiting
Location: See location...
Intervention Type: Drug, Diagnostic test
Study Type: Interventional
Study Phase: Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Georgia
Emory Healthcare System
RECRUITING
Atlanta
Contact Information
Primary
Aaron Trammell, MD, MSc
awtramm@emory.edu
404-712-8204
Backup
Jane Gillespie, RN
jegille@emory.edu
404-712-8204
Time Frame
Start Date: 2024-12-17
Estimated Completion Date: 2028-02
Participants
Target number of participants: 20
Treatments
Experimental: Pioglitazone, Then Placebo
Participants will first receive a 30 mg tablet of Pioglitazone once daily for 28 days. After a washout period of 14 days, they will then receive a Placebo tablet (matching Pioglitazone 30 mg tablet) once daily for 28 days.
Experimental: Placebo, Then Pioglitazone
Participants will first receive a Placebo for 28 days. After a washout period of 14 days, they will then receive a 30 mg Pioglitazone tablet once daily for 28 days.
Related Therapeutic Areas
Sponsors
Leads: Emory University
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov