Using Deferiprone to Treat Heart Damage After a Heart Attack
Cardiac MRI-guided Deferiprone Therapy for Acute Myocardial Infarction Patients
This study is testing if the medication Deferiprone can help reduce heart damage in patients who have had a heart attack by lowering iron levels in their hearts.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 89 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT05604131 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the effectiveness of Deferiprone, a medication, in reducing free iron levels in the hemorrhagic zone of patients who have experienced an acute myocardial infarction. Participants will be randomly assigned to receive either Deferiprone tablets or a placebo. The study focuses on patients with anterior wall STEMI who undergo emergency coronary angiography with primary PCI. The goal is to determine if Deferiprone can improve outcomes in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have experienced an index anterior wall STEMI and are undergoing emergency coronary angiography.
Not a fit: Patients with a history of significant heart issues, certain medical conditions, or contraindications to cardiac MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery and outcomes for patients suffering from acute myocardial infarction.
How similar studies have performed: While this approach is novel, similar studies targeting iron reduction in myocardial infarction have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 1. Age 18-79 years 2. Index Anterior wall STEMI 3. Emergency coronary angiogram with primary PCI Exclusion Criteria 1. Prior history of MI / PCI / coronary artery bypass graft (CABG) within previous 1 year 2. Patients with previous history of left ventricular ejection fraction (LVEF) \< 40% 3. Use of investigational drugs or devices 30 days prior to randomization 4. Known allergy or contra-indication to gadolinium/contrast agents 5. eGFR \< 30 ml/kg/min 6. Any contraindication against cardiac MRI (such as metal implants) 7. Women who are pregnant or breastfeeding. Women of reproductive potential must have a negative pregnancy test prior to randomization 8. Body weight \> 140 kg (or 309 lbs.) 9. Absolute neutrophil count - ANC \< 1.5 k/cumm 10. History of Chronic Liver Disease 11. Elevated hepatic enzymes (BOTH ALT and AST) \> 2 times of upper normal limit 12. Patients with iron storage disease (hemochromatosis, thalassemia) or who are already treated with iron chelators 13. Any clinically significant abnormality identified prior to randomization that in the judgment of the Sponsor-Investigator or Delegate would preclude safe completion of the study or confound the anticipated benefit of deferiprone. 14. Life expectancy of less than 1 year due to non-cardiac pathology
Where this trial is running
Indianapolis, Indiana
- IU Methodist Hospital (IUHealth) — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Principal investigator: Keyur P Vora, MD FACP FACC — Medical Imaging Research Institute, Indiana University School of Medicine
- Study coordinator: Clinical Research Coordinator
- Email: csaha@iu.edu
- Phone: (317) 274-0985
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.