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NCT05775380: PREVALENT

The Role of Pioglitazone in Vascular Transcriptional Remodeling

Status unknown Phase 4 Last updated 12 January 2024
What this trial tests

Phase 4 trial testing Pioglitazone 45 mg in Myocardial Reperfusion Injury in 20 participants. Status unknown.

Timeline
15 June 2023
Primary endpoint
28 June 2024
22 December 2024

Quick facts

Lead sponsorUniversity of Campinas, Brazil
PhasePhase 4
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeprevention
Enrollment20
Start date15 June 2023
Primary completion28 June 2024
Estimated completion22 December 2024
Sites1 location across Brazil

Drugs / interventions tested

Conditions studied

Sponsor

University of Campinas, Brazil

Who can join

Adults 40 to 70, male only, with Myocardial Reperfusion Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Acute myocardial infarction (AMI) remains the leading cause of death worldwide. In this scenario, early coronary reperfusion is the main therapeutic strategy as it substantially reduces mortality. Paradoxically, however, reperfusion triggers additional tissue damage that accounts for about 50% of the infarcted heart mass, i.e., ischemia and reperfusion injury (IRL). In this context, sphingosine-1-phosphate (S1P) is a sphingolipid synthesized by sphingosine kinases (Sphk), carried in plasma bound to high-density lipoprotein (HDL) and released after cellular damage such as LIR. Particularly, in animal models of AMI, therapies targeting downstream S1P receptor signaling triggered by HDL/S1P are able to promote endothelial barrier functions and attenuate secondary damage to LIR. Thus, the molecular control of sphingosine kinase 1 (Sphk1) transcription during LIR in vivo or during hypoxia/reoxygenation (H/R) in vitro may represent an important mechanism for maintaining endothelial homeostasis since it promotes the generation of S1P and this may promote subsequent HDL enrichment. Thus, the role of pioglitazone hydrochloride 45mg/day for five days in volunteers undergoing coronary artery bypass grafting (BVR) will be investigated in order to verify the vascular expression of SPhk1, transcriptome and vascular proteome remodeling, as well as S1P content in HDL.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Pioglitazone 45 mg

Trials testing the same drug.

Other recruiting trials for Myocardial Reperfusion Injury

Currently open trials in the same condition.

Other University of Campinas, Brazil trials

Trials by the same sponsor.

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Data sources for this page

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