RecruitingPhase 2NCT06336798

Bioenergetic Effect of Pioglitazone in CLD-PH

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


Sponsor

Emory University

Enrollment

20 participants

Start Date

Dec 17, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether pioglitazone — a diabetes medication — can improve how the heart and lungs use energy in people with pulmonary hypertension caused by chronic lung disease (CLD-PH). This type of high blood pressure in the lungs is difficult to treat, and researchers hope this drug may help. **You may be eligible if...** - You have been diagnosed with pulmonary hypertension caused by chronic lung disease, confirmed by a right heart catheterization - Your pulmonary hypertension meets specific pressure and resistance criteria from the catheter test - You are on stable doses of any approved pulmonary hypertension medications - You are willing and able to take oral medication and follow study procedures **You may NOT be eligible if...** - You have pulmonary hypertension caused by something other than chronic lung disease (e.g., heart failure or blood clots) - You have certain other serious conditions that would make pioglitazone unsafe - You are pregnant or planning pregnancy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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).


Locations(1)

Emory Healthcare System

Atlanta, Georgia, United States

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NCT06336798


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