The Role of Pioglitazone in Vascular Transcriptional Remodeling

Launched by UNIVERSITY OF CAMPINAS, BRAZIL · Mar 17, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called pioglitazone to see how it affects blood vessel healing after a heart attack. When someone has a heart attack, restoring blood flow quickly is crucial to saving heart muscle, but this process can sometimes cause additional damage. Researchers believe that pioglitazone might help reduce this damage by influencing certain molecules in the body that support blood vessel health.

To be eligible for this trial, participants must be male, over 40 years old, and undergoing heart surgery known as coronary artery bypass grafting (CABG). They should have a healthy body weight and specific heart function measurements. Participants will take pioglitazone for five days and will have their blood and tissue samples analyzed to see how their blood vessels respond. It's important to know that certain health conditions or previous medications could prevent someone from joining the study. This trial aims to improve treatment approaches for heart attack patients and their recovery.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Male individuals
• • Individuals undergoing CABG surgery for coronary artery disease
• • Be over 40 years of age
• • BMI between 20 and 34.9kg/m2
• • Non-diabetic or if diabetic, disease duration \< 10 years, Hba1c \< 8%, non-user of NPH insulin
• • Ejection fraction \> 40%
• • Glomerular filtration rate \> 45 mL/min
• Exclusion Criteria:
• • BMI greater than 35 kg/m2, steatohepatitis, chronic kidney disease, systemic vasculitis, conditions that induce systemic inflammation such as psoriasis and systemic lupus erythematosus
• • contraindications to the use of pioglitazone hydrochloride (heart failure, liver failure - AST or ALT \> 2.5x upper normal limit, history of bladder cancer or macroscopic hematuria without investigation)
• • moderate or severe valve disease
• • need for concomitant use of other hypoglycemic therapies during hospitalization, particularly insulin
• • peripheral edema
• • recent hospitalization
• • known allergy to any study drug
• • polyuria, polydipsia, weight loss, or other clinical signs of volume depletion or diabetes, difficult-to-control systemic arterial hypertension, defined as individuals taking 4 or more drugs
• • those who withdraw the Informed Consent Form (TCLE), or who, for some reason, are not able to sign or understand the TCLE
• • history of gastrointestinal disorders that may interfere with study drug absorption
• • research participant who is participating in other clinical trials or whose participation ended less than six months ago
• • Research participant who has left ventricular dysfunction