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Thiazolidinedione

Pioglitazone for Pulmonary Hypertension

Phase 2

Recruiting

Led By Aaron Trammell

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed to have pulmonary hypertension (PH) due to chronic lung disease at screening; Diagnosis must be confirmed by right heart catheterization. Right heart catheterization must be within 1 year of screening.

Ability to take oral medication and be willing to adhere to the study intervention regimen

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1, day 28, day 70

Summary

This trial aims to study the safety and effectiveness of Pioglitazone in people with Pulmonary Hypertension caused by Chronic Lung Disease. The main question is whether Pioglitazone affects

Who is the study for?

This trial is for individuals with Pulmonary Hypertension due to Chronic Lung Disease, confirmed by a test within the last year. Participants must be able to take oral medication and follow study procedures, including fasting before visits. Women who can have children and men must use effective contraception during the study.

What is being tested?

The trial tests if Pioglitazone affects mitochondrial oxygen utilization in PH patients with CLD. It involves taking Pioglitazone or a placebo daily for 28 days, a two-week break, then switching treatments for another 28 days.

What are the potential side effects?

Possible side effects of Pioglitazone include weight gain, swelling due to fluid retention (edema), fatigue, headache, muscle pain, respiratory tract infections and an increased risk of bone fractures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My pulmonary hypertension due to lung disease was confirmed by a heart test within the last year.

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I can take pills and will follow the study's treatment plan.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, day 28, day 70

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, day 28, day 70

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 28, day 70 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Mitochondrial metabolism parameters: Basal respiration

Change in Mitochondrial metabolism parameters: Maximal respiration

Change in Mitochondrial metabolism parameters: Spare respiratory capacity

Secondary study objectives

Change in BNP levels

Change in Borg dyspnea score

Change in NYHA/WHO Functional Classification

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Placebo, Then PioglitazoneExperimental Treatment3 Interventions

Participants will first receive a Placebo for 28 days. After a washout period of 14 days, they will then receive a 30 mg Pioglitazone tablet once daily for 28 days.

Group II: Pioglitazone, Then PlaceboExperimental Treatment3 Interventions

Participants will first receive a 30 mg tablet of Pioglitazone once daily for 28 days. After a washout period of 14 days, they will then receive a Placebo tablet (matching Pioglitazone 30 mg tablet) once daily for 28 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 2Eligibility criteria met