Health TrialsbyHealthPanel

Bioenergetic Effect of Pioglitazone in CLD-PH

ConditionsPulmonary HypertensionPulmonary Hypertension Due to Lung Diseases
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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • Pioglitazone 30mg

    Drug

    Study participants will take Pioglitazone 30 mg PO daily

  • Placebo

    Drug

    Study participants will take a placebo PO daily

  • Labs

    Diagnostic test

    Labs will be performed for Urine HCG, Complete Blood count (CBC), Chemistry Panel, Fasting lipids, insulin, glucose, and Bioenergetic analysis (platelets).

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Pioglitazone, Then PlaceboExperimental treatment 3 interventions
Group B: Placebo, Then PioglitazoneExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Change in Mitochondrial metabolism parameters: Spare respiratory capacity

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.

Time frame
Day 1, Day 28, Day 70
2

Change in Mitochondrial metabolism parameters: Maximal respiration

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.

Time frame
Day 1, Day 28, Day 70
3

Change in Mitochondrial metabolism parameters: Basal respiration

Basal respiration is calculated by (Baseline) - (nonmitochondrial respiration) ) during the mitochondrial stress test. The value is reported in pmol/min.

Time frame
Day 1, Day 28, Day 70

Secondary outcomes

1

Number of hypoglycemia incidences

Participants experiencing symptoms of hypoglycemia will be identified and reported.

Time frame
Day 1, Day 28, Day 70
2

Number of participants with leg edema

Participants reporting edema (\>2) will be captured.

Time frame
Day 1, Day 28, Day 70
3

Change in BNP levels

Change in Brain Natriuretic Peptide from the baseline will be calculated. Unit is pg/ml

Time frame
Day 1, Day 28, Day 70
4

Change in Six minute walk distance (6MWT)

The six-minute walk test (6MWT) is a standardized test of exercise capacity commonly used in patients with heart failure, lung disease, PH, and in pre-lung transplant evaluation. Results will be recorded as the distance walked in meters.

Time frame
Day 1, Day 28, Day 70

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Emory University

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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