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Iron Chelator
Deferiprone Therapy for Heart Attack (MIRON-DFP Trial)
Phase 1 & 2
Recruiting
Led By Rohan Dharmakumar, PhD
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
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 moreOther 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
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.
Acute changes in iron metabolism following myocardial infarction.
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Who is running the clinical trial?
Rohan DharmakumarLead Sponsor
8 Previous Clinical Trials
201,957 Total Patients Enrolled
Cardio-theranostics LLCUNKNOWN
Lipomed AGUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My body weight is over 309 lbs.My liver enzymes are high, and I'm not on chronic liver disease medication.My doctor expects I have less than 1 year to live due to a non-heart related condition.I have a history of heart attack or heart surgery.My heart's pumping ability is below 40%.I am allergic to gadolinium/contrast agents.My kidney function is severely reduced.I have a condition like hemochromatosis or thalassemia, or I am being treated with iron chelators.I had a specific type of heart attack affecting the front wall of my heart, confirmed by symptoms, ECG changes, and high heart markers.
Research Study Groups:
This trial has the following groups:- Group 1: Hemorrhagic Myocardial Infarction - Deferiprone
- Group 2: Non-hemorrhagic Myocardial Infarction - Deferiprone
- Group 3: Hemorrhagic Myocardial Infarction - Placebo
- Group 4: Non-hemorrhagic Myocardial Infarction - Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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