Bioenergetic Effect of Pioglitazone in CLD-PH
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University
About this trial
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 criteria
Qualifiers
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
Mean pulmonary artery pressure >20 mmHg
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Pioglitazone 30mg
- Placebo
- Labs
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Emory University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov