What side effects are associated with this type of intervention?

Common treatments for heart attacks include medications such as aspirin, beta-blockers, ACE inhibitors, and statins. Aspirin can cause gastrointestinal bleeding and ulcers. Beta-blockers may lead to fatigue, cold extremities, and bradycardia. ACE inhibitors can cause cough, elevated blood potassium levels, and kidney dysfunction. Statins are associated with muscle pain, liver enzyme abnormalities, and a small risk of diabetes. For iron chelation therapy like Deferiprone, side effects may include gastrointestinal disturbances, joint pain, and a risk of agranulocytosis, which is a severe drop in white blood cells.

What prior FDA approvals exist?

The FDA has approved various treatments for heart attacks, primarily focusing on restoring blood flow and preventing further clotting. Commonly approved treatments include thrombolytic agents (clot busters), antiplatelet drugs (such as aspirin), anticoagulants, and beta-blockers. While Deferiprone, an iron chelation therapy, is being studied for its efficacy in reducing iron levels in myocardial infarction patients, there is no specific mention of FDA approval for iron chelation therapies in the context of heart attack treatment.

What other types of research exist?

Promising alternatives to Deferiprone for iron chelation in heart attack patients include Deferasirox and Deferoxamine. Both have shown efficacy in reducing iron overload and have been studied in various clinical settings. Deferasirox is an oral iron chelator with a favorable safety profile, while Deferoxamine is administered intravenously or subcutaneously and is effective in acute settings. These alternatives may offer different administration routes and safety profiles, providing options for personalized treatment plans.

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Iron Chelator

Deferiprone Therapy for Heart Attack (MIRON-DFP Trial)

Phase 2

Recruiting

Led By Keyur P Vora, MD FACP FACC

Research Sponsored by Rohan Dharmakumar

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Summary

This trial is testing Deferiprone, a medication that removes excess iron, in patients with bleeding in the heart muscle. The goal is to see if it can reduce heart damage by getting rid of extra iron. Deferiprone is effective in reducing cardiac iron load and improving cardiac function.

Who is the study for?

This trial is for adults who've recently had a specific type of heart attack (anterior wall STEMI) and are about to have a procedure to open their blocked arteries. They must not have had previous heart attacks or procedures, severe kidney issues, known allergies to MRI contrast agents, or be pregnant. Their body weight should be under 309 lbs., and they can't have certain blood disorders or liver problems.

What is being tested?

The study tests if Deferiprone tablets can reduce iron in the damaged area of the heart after a hemorrhagic myocardial infarction. Patients will either receive Deferiprone or a placebo randomly, alongside standard care including an MRI scan to guide treatment.

What are the potential side effects?

Deferiprone may cause side effects like nausea, vomiting, joint pain, and changes in liver function tests. It might also lead to neutropenia (a drop in white blood cells), which increases infection risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Therapeutic procedure

Secondary study objectives

Safety and Tolerability - Rate of Discontinuation

Safety and Tolerability - Reversibility of Side Effects without Treatment

Safety and Tolerability - Severe Side Effects

+2 more

Other study objectives

Treatment Effect: Fat Infiltration

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Hemorrhagic Myocardial Infarction - DeferiproneActive Control1 Intervention

Enrolled patients with CMR confirmed presence of intramyocardial hemorrhage

Group II: Non-hemorrhagic Myocardial Infarction - DeferiproneActive Control1 Intervention

Enrolled patients with CMR confirmed absence of intramyocardial hemorrhage

Group III: Hemorrhagic Myocardial Infarction - PlaceboPlacebo Group1 Intervention

Enrolled patients with CMR confirmed presence of intramyocardial hemorrhage

Group IV: Non-hemorrhagic Myocardial Infarction - PlaceboPlacebo Group1 Intervention

Enrolled patients with CMR confirmed absence of intramyocardial hemorrhage

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for heart attacks include medications like aspirin, beta-blockers, ACE inhibitors, and statins, which work by reducing blood clot formation, lowering heart rate and blood pressure, and reducing cholesterol levels, respectively. Deferiprone, an iron chelation therapy, specifically targets free unbound iron in the hemorrhagic zone of myocardial infarction. This is crucial because excess iron can catalyze the formation of free radicals, leading to further tissue damage. By reducing iron levels, Deferiprone may help limit oxidative stress and tissue injury, potentially improving outcomes for heart attack patients.

Acute changes in iron metabolism following myocardial infarction.