drugset / Trial / NCT05317806

Metformin Use in Cardiac Fibrosis in PAI-1 Deficiency

NCT05317806 ↗

Phase 4 Active not recruiting 15 enrolled Indiana Hemophilia &Thrombosis Center, Inc.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study will evaluate the efficacy and safety of metformin, in patients 18-65 years of age with homozygous plasminogen activator inhibitor-1 (PAI-1) deficiency, with or without cardiac fibrosis, for a period of 60 months. The starting dose of metformin will be 500 mg up to a maximum dose of 2000 mg for a period of 5 years with the aim to assess the safety and efficacy of metformin on prevention/stabilization or regression of cardiac fibrosis in a Treated population vs. a Comparison population.

Timeline

Start
2022-10-10
Primary completion
2027-10
Completion
2027-10

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 2000 mg Oral