Bioenergetic Effect of Pioglitazone in CLD-PH

Description

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

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Study Overview

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Study Details

Study overview

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).

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

Bioenergetic Effect of Pioglitazone in CLD-PH

Condition
Pulmonary Hypertension
Intervention / Treatment

-

Contacts and Locations

Atlanta

Emory Healthcare System, Atlanta, Georgia, United States, 30322

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Provision of 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 1 within 1 year of screening:
  • * 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 prior to arrival for the study visit.
  • * Diabetes mellitus (type 1 or type 2), present within the preceding 1 year
  • * Personal history of symptomatic hypoglycemia within 90 days preceding enrollment
  • * Personal outpatient use of pioglitazone, rosiglitazone, metformin, insulin, or other medications for the indication of diabetes within 90 days preceding enrollment
  • * History of left ventricular failure (systolic or diastolic)
  • * Pulmonary hypertension due to Group 2 PH (PH due to left heart disease)
  • * History of prior or active bladder cancer
  • * Thrombocytopenia (diagnosis or known platelet count ≤120) within 90 days preceding enrollment
  • * Platelet count ≤120 during screening or on the day of enrollment hypertension due to chronic lung disease
  • * Cystic fibrosis
  • * Pregnancy or lactation
  • * Current tobacco use
  • * Known allergic reaction to components of the study medication (pioglitazone)
  • * Treatment with another investigational drug within 30 days

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Emory University,

Aaron Trammell, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

2028-02