Using Pioglitazone to Improve Heart Recovery After Surgery

The Role of Pioglitazone in Vascular Transcriptional Remodeling in Individuals Undergoing Coronary Artery Bypass Grafting

This study is testing if a medication called pioglitazone can help men over 40 recover better after heart surgery by improving their blood vessel health.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 40 Years to 70 Years
• Sex: Male
• Sponsor: University of Campinas, Brazil (other)
• Locations: 1 site (Campinas, SP)
• Trial ID: NCT05775380 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of pioglitazone hydrochloride on patients undergoing coronary artery bypass graft (CABG) surgery for myocardial reperfusion injury. It is a prospective, randomized, and open-label study involving male participants over 40 years old, both diabetic and non-diabetic, who meet specific health criteria. Participants will receive pioglitazone for five days prior to surgery, and various biomarkers will be measured to assess the drug's impact on vascular health and recovery. The study aims to understand how pioglitazone influences sphingosine-1-phosphate levels and endothelial function during the surgical recovery process.

Who should consider this trial

Good fit: Ideal candidates are male patients over 40 years old undergoing CABG surgery, with specific health criteria including controlled diabetes or non-diabetes.

Not a fit: Patients with severe obesity, chronic kidney disease, or contraindications to pioglitazone will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance heart recovery and reduce damage during and after surgery for patients with coronary artery disease.

How similar studies have performed: While the specific use of pioglitazone in this context may be novel, previous studies have shown promise in targeting sphingosine-1-phosphate signaling for improving vascular outcomes.

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

Where this trial is running

Campinas, SP

• University of Campinas — Campinas, SP, Brazil (RECRUITING)

Study contacts

• Principal investigator: Andrei Sposito, Professor — University of Campinas, Brazil
• Study coordinator: Andrei Sposito, Professor

Conditions: Myocardial Reperfusion Injury