Bioenergetic Effect of Pioglitazone in CLD-PH

Korábbi kezelés

• History of prior or active bladder cancer
• Treatment with another investigational drug within 30 days

Más betegség

• 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)
• Known allergic reaction to components of the study medication (pioglitazone)

Laborértékek

• 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

Egyéb

• Cystic fibrosis
• Pregnancy or lactation
• Current tobacco use

• 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.