Bioenergetic Effect of Pioglitazone in CLD-PH
NCT06336798 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2025-07-03
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).
Conditions
- Pulmonary Hypertension
- Pulmonary Hypertension Due to Lung Diseases
Interventions
- DRUG
-
Pioglitazone 30mg
Study participants will take Pioglitazone 30 mg PO daily
- DRUG
-
Study participants will take a placebo PO daily
- DIAGNOSTIC_TEST
-
Labs
Labs will be performed for Urine HCG, Complete Blood count (CBC), Chemistry Panel, Fasting lipids, insulin, glucose, and Bioenergetic analysis (platelets).
Sponsors & Collaborators
-
National Heart, Lung, and Blood Institute (NHLBI)
collaborator NIH -
Emory University
lead OTHER
Principal Investigators
-
Aaron Trammell · Emory University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-17
- Primary Completion
- 2028-02-29
- Completion
- 2028-02-29
- FDA Drug
- Yes
Countries
- United States
Study Locations
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