MedTrace Logo

Metformin Use in Cardiac Fibrosis in PAI-1 Deficiency

NCT05317806 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-11-06

No results posted yet for this study

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.

Conditions

  • Plasminogen Activator Inhibitor-1 Deficiency
  • Cardiac Fibrosis

Interventions

DRUG

Metformin Extended Release Oral Tablet

daily metformin treatment vs. no treatment with metformin

Sponsors & Collaborators

  • Indiana Hemophilia &Thrombosis Center, Inc.

    lead OTHER

Principal Investigators

  • Sweta Gupta, MD · Indiana Hemophilia and Thrombosis Center, Inc

  • Magdalena Lewandowska, MD · Indiana Hemophilia and Thrombosis Center, Inc

  • Amy D Shapiro, MD · Indiana Hemophilia and Thrombosis Center, Inc

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-10
Primary Completion
2027-10-31
Completion
2027-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05317806 on ClinicalTrials.gov