RECRUITING

Bioenergetic Effect of Pioglitazone in CLD-PH

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Conditions

Pulmonary HypertensionPulmonary Hypertension Due to Lung DiseasesChronic Lung DiseasePioglitazone

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2025-01
Study Completion:2028-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06336798

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of signed and dated informed consent form
  2. * Stated willingness to comply with all study procedures for the duration of the study
  3. * Confirmed to have pulmonary hypertension (PH) due to chronic lung disease at screening
  4. * Pulmonary hypertension is defined based on meeting all three of the following measured at rest during the RHC 1 within 1 year of screening:
  5. * Mean pulmonary artery pressure \>20 mmHg
  6. * Pulmonary artery wedge pressure ≤15 mmHg
  7. * Pulmonary vascular resistance \> 2 Wood units
  8. * Pulmonary hypertension is classified in Group 3: PH associated with lung diseases and/or hypoxia
  9. * Medications approved for the treatment of pulmonary hypertension must be at a stable dose for at least 30 days
  10. * Ability to take oral medication and be willing to adhere to the study intervention regimen
  11. * 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.
  12. * For males of reproductive potential: use of condoms or other methods to ensure effective contraception with a partner
  13. * 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.
  1. * Diabetes mellitus (type 1 or type 2), present within the preceding 1 year
  2. * Personal history of symptomatic hypoglycemia within 90 days preceding enrollment
  3. * Personal outpatient use of pioglitazone, rosiglitazone, metformin, insulin, or other medications for the indication of diabetes within 90 days preceding enrollment
  4. * History of left ventricular failure (systolic or diastolic)
  5. * Pulmonary hypertension due to Group 2 PH (PH due to left heart disease)
  6. * History of prior or active bladder cancer
  7. * Thrombocytopenia (diagnosis or known platelet count ≤120) within 90 days preceding enrollment
  8. * Platelet count ≤120 during screening or on the day of enrollment hypertension due to chronic lung disease
  9. * Cystic fibrosis
  10. * Pregnancy or lactation
  11. * Current tobacco use
  12. * Known allergic reaction to components of the study medication (pioglitazone)
  13. * Treatment with another investigational drug within 30 days

Contacts and Locations

Study Contact

Aaron Trammell, MD, MSc
CONTACT
404-712-8204
awtramm@emory.edu
Jane Gillespie, RN
CONTACT
404-712-8204
jegille@emory.edu

Principal Investigator

Aaron Trammell
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Emory Healthcare System
Atlanta, Georgia, 30322
United States

Collaborators and Investigators

Sponsor: Emory University

  • Aaron Trammell, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01
Study Completion Date2028-02

Study Record Updates

Study Start Date2025-01
Study Completion Date2028-02

Terms related to this study

Keywords Provided by Researchers

  • Pulmonary Hypertension
  • Chronic Lung Disease
  • Pioglitazone

Additional Relevant MeSH Terms

  • Pulmonary Hypertension
  • Pulmonary Hypertension Due to Lung Diseases