Bioenergetic Effect of Pioglitazone in CLD-PH
Effect of Pioglitazone on Mitochondrial Metabolism in Pulmonary Hypertension Due to Chronic Lung Disease
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 28 days
- Procedures mentioned: Blood draws
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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)."
- "The investigators and others have shown that bioenergetics can be measured in isolated platelets obtained from a peripheral blood draw in patients with PH and other diseases."
- "In this study, the team will assess the effect of pioglitazone on bioenergetic parameters in platelets isolated from whole blood samples."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety and effects of pioglitazone in people with high blood pressure in the lungs caused by long-term lung disease. It looks at how the drug affects oxygen use by the energy-making parts of cells. Participants take pioglitazone and a placebo (a pill with no study drug), each once a day for 28 days, with a 2-week break between them.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Sign and date a consent form and agree to follow study rules.
- Have high blood pressure in the lungs caused by long-term lung disease or low oxygen, confirmed by heart pressure tests.
- Have no dose changes to approved medicines for high blood pressure in the lungs for at least 30 days.
- Be able and willing to take the study pills as directed.
- Women who can become pregnant must use highly effective birth control during the study and for 4 weeks afterward.
- Men who can father a child must use condoms or another effective birth control method with a partner.
- Have no food or drinks with calories for 6 hours before study visits.
Who can't join
- Type 1 or type 2 diabetes within the past year, or low blood sugar that caused symptoms within the past 90 days.
- Use of diabetes medicines outside the hospital within the past 90 days, including pioglitazone, rosiglitazone, metformin, or insulin.
- Past failure of the heart’s left pumping chamber, or high blood pressure in the lungs caused by left-sided heart disease.
- Current or past bladder cancer, or cystic fibrosis.
- Low platelets (blood cells that help stop bleeding) within the past 90 days, or a platelet count of 120 or less at screening or enrollment.
- Pregnant, breastfeeding, or currently using tobacco.
- Known allergy to any part of pioglitazone.
- Treatment with another experimental drug within the past 30 days.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Provision of a 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: * 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 before arrival for the study visit. Exclusion Criteria: * 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
Study sites (1)
GA
- Emory Healthcare System · Atlanta, GA 30322Jane Gillespie, RN · Study contact · 404-712-8204 · jegille@emory.eduAaron W Trammell, MD, MSc · Principal investigatorMore trials in Atlanta