Actively Recruiting
Bioenergetic Effect of Pioglitazone in CLD-PH
Led by Emory University · Updated on 2025-07-03
20
Participants Needed
1
Research Sites
163 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Bioenergetic Effect of Pioglitazone in CLD-PH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form provided
- Willingness to follow all study procedures for the entire study
- Confirmed pulmonary hypertension due to chronic lung disease at screening defined by mean pulmonary artery pressure >20 mmHg, pulmonary artery wedge pressure ≤15 mmHg, and pulmonary vascular resistance > 2 Wood units
- Pulmonary hypertension classified as Group 3 associated with lung diseases or hypoxia
- Stable dose of approved pulmonary hypertension medications for at least 30 days
- Ability to take oral medication and willingness to follow study treatment
- For females of reproductive potential: agreement to use highly effective contraception during the study and for 4 weeks after
- For males of reproductive potential: use of condoms or other effective contraception methods with partners
- Agreement to follow fasting requirements before clinic visits as specified
You will not qualify if you...
- Diabetes mellitus (type 1 or 2) within the past year
- History of symptomatic hypoglycemia within 90 days before enrollment
- Use of pioglitazone, rosiglitazone, metformin, insulin, or other diabetes medications within 90 days before enrollment
- History of left ventricular failure (systolic or diastolic)
- Pulmonary hypertension due to left heart disease (Group 2 PH)
- History of bladder cancer (prior or active)
- Thrombocytopenia or platelet count ≤120 within 90 days before enrollment or at screening
- Cystic fibrosis
- Pregnancy or breastfeeding
- Current tobacco use
- Known allergy to pioglitazone or its components
- Treatment with another investigational drug within 30 days before enrollment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Emory Healthcare System
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
A
Aaron Trammell, MD, MSc
CONTACT
J
Jane Gillespie, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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