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NCT Number: NCT05604131

Cardiac MRI-guided Deferiprone Therapy for Acute Myocardial Infarction Patients

The objective of this randomized, controlled pilot study is to determine the efficacy of Deferiprone to reduce the amount of free iron inside the hemorrhagic zone of myocardial infarction among hemorrhagic myocardial infarction patients.

Recruiting

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

IU Methodist Hospital (IUHealth)

Indianapolis, Indiana, 46202, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-79 years
  • Index Anterior wall STEMI
  • Emergency coronary angiogram with primary PCI

Exclusion criteria

  • Prior history of MI / PCI / coronary artery bypass graft (CABG) within previous 1 year
  • Patients with previous history of left ventricular ejection fraction (LVEF) < 40%
  • Use of investigational drugs or devices 30 days prior to randomization
  • Known allergy or contra-indication to gadolinium/contrast agents
  • eGFR < 30 ml/kg/min
  • Any contraindication against cardiac MRI (such as metal implants)
  • Women who are pregnant or breastfeeding. Women of reproductive potential must have a negative pregnancy test prior to randomization
  • Body weight > 140 kg (or 309 lbs.)
  • Absolute neutrophil count - ANC < 1.5 k/cumm
  • History of Chronic Liver Disease
  • Elevated hepatic enzymes (BOTH ALT and AST) > 2 times of upper normal limit
  • Patients with iron storage disease (hemochromatosis, thalassemia) or who are already treated with iron chelators
  • 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.
  • Life expectancy of less than 1 year due to non-cardiac pathology

Treatment and study plan

Deferiprone Tablets

Drug

Deferiprone tablets are the active medication for the active arm of the study groups. Randomization will be done by investigational drug services pharmacist and intervention will be double-blinded to investigators and patients.

Placebo

Drug

Deferiprone placebo is the non-medicated formulation for a control arm of the study groups.

Primary outcomes

  1. Treatment Efficacy

    Time frame: 6 months

    Percentage reduction of hemorrhagic zone iron content by cardiac magnetic resonance at 6 months relative to baseline

Secondary outcomes

  1. Treatment Effect: Clinical Outcomes of Acute Heart Failure

    Time frame: 6 months

    The proportion of subjects who experience an acute heart failure event

  2. Treatment Effect: Clinical Outcomes of Non-Fatal Cardiovascular morbidity

    Time frame: 6 months

    The proportion of subjects who experience other non-fatal cardiovascular morbidity such as recurrent myocardial infarction, ventricular arrhythmia and CVA

  3. Safety and Tolerability - Rate of Discontinuation

    Time frame: 6 months

    Rate of discontinuation of therapy due to side effects

  4. Safety and Tolerability - Severe Side Effects

    Time frame: 6 months

    Rate of severe side effects requiring hospitalization, extension of length-of-stay.

  5. Safety and Tolerability - Reversibility of Side Effects without Treatment

    Time frame: 6 months

    Percentage of Reversible of Side Effects without treatment

Other outcomes

  1. Treatment Effect: Fat Infiltration

    Time frame: 6 months

    Percentage difference of fat infiltration within the hemorrhagic myocardial infarction arms at 6 months between deferiprone and placebo groups

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Research Coordinator

CONTACT

[email protected]

(317) 274-0985

Sponsors and collaborators

Lead sponsor

Rohan Dharmakumar

Other

Collaborators

  • Minneapolis Heart Institute

Registry information

Acronym: MIRON-DFP

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Nov 3, 2022
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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