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

NCT06336798 Phase 2 RECRUITING

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).

Details

Lead sponsor	Emory University
Phase	Phase 2
Status	RECRUITING
Enrolment	20
Start date	2024-12-17
Completion	2028-02

Conditions

• Pulmonary Hypertension
• Pulmonary Hypertension Due to Lung Diseases

Interventions

• Pioglitazone 30mg
• Placebo
• Labs

Primary outcomes

• Change in Mitochondrial metabolism parameters: Spare respiratory capacity — Day 1, Day 28, Day 70
  Mitochondrial metabolism is measured using a research protocol employing the Agilent Seahorse extracellular flux bioanalyzer. Standard Seahorse assay protocols have been adapted for use with human platelets . Spare respiratory capacity (SRC) is calculated by (maximal respiration) - (basal respiration) during the mitochondrial stress test. The value is reported in pmol/min.
• Change in Mitochondrial metabolism parameters: Maximal respiration — Day 1, Day 28, Day 70
  Maximal Respiration is calculated by: (post-carbonyl cyanide 4-(trifluoromethoxy) phenylhydrazone(FCCP) - (nonmitochondrial respiration) during the mitochondrial stress test. The value is reported in pmol/min.
• Change in Mitochondrial metabolism parameters: Basal respiration — Day 1, Day 28, Day 70
  Basal respiration is calculated by (Baseline) - (nonmitochondrial respiration) ) during the mitochondrial stress test. The value is reported in pmol/min.

Countries

United States