Acute Myocardial Infarction Type 1Phase 2MIRON-DFPNCT05604131
Cardiac MRI-guided Deferiprone Therapy for Acute Myocardial Infarction Patients
A Phase 2 study testing Deferiprone Tablets in people with Acute Myocardial Infarction Type 1, run by Rohan Dharmakumar at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction Type 1
- What is being tested?
- Deferiprone Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Nov 2022to 31 Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Index Anterior wall STEMI
- Emergency coronary angiogram with primary PCI
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
IU Methodist Hospital (IUHealth)
Indianapolis, Indiana, 46202
Chandana Saha, PhD, 317-274-0985, csaha@iu.edu
- Recruiting
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Colleen Quinlan, 763-688-7451, colleen.quinlan@allina.com
Jay Traverse, MD
About this study
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.
Read the detailed description
Patients with newly diagnosed STEMI (ST-segment elevation myocardial infarction) who appear to meet eligibility criteria will be recruited for participation. Those who agree to participate and are confirmed to be eligible will undergo a cardiac MRI scan and will be randomized to take either deferiprone or placebo daily for 60 days. Total study participation will last 6 months, during which study participants will attend 7 study visits for blood draws, ECGs, and a repeat cardiac MRI at Day 180.
- Conditions
- Acute Myocardial Infarction Type 1
- Being tested
- Deferiprone Tablets, Placebo
- Keywords
- Acute Myocardial Infarction, Intramyocardial Hemorrhage, Deferiprone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deferiprone TabletsDrug
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.
PlaceboDrug
Deferiprone placebo is the non-medicated formulation for a control arm of the study groups.
| Study group | Role | What they receive |
|---|---|---|
| Hemorrhagic Myocardial Infarction - Deferiprone | Active comparator | Enrolled patients with CMR confirmed presence of intramyocardial hemorrhage Receives: Drug: Deferiprone Tablets |
| Non-hemorrhagic Myocardial Infarction - Deferiprone | Active comparator | Enrolled patients with CMR confirmed absence of intramyocardial hemorrhage Receives: Drug: Deferiprone Tablets |
| Hemorrhagic Myocardial Infarction - Placebo | Placebo comparator | Enrolled patients with CMR confirmed presence of intramyocardial hemorrhage Receives: Drug: Placebo |
| Non-hemorrhagic Myocardial Infarction - Placebo | Placebo comparator | Enrolled patients with CMR confirmed absence of intramyocardial hemorrhage Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Efficacy
Percentage reduction of hemorrhagic zone iron content by cardiac magnetic resonance at 6 months relative to baseline
Measured: 6 months
Secondary outcomes (5)
Treatment Effect: Clinical Outcomes of Acute Heart Failure
The proportion of subjects who experience an acute heart failure event
Measured: 6 months
Treatment Effect: Clinical Outcomes of Non-Fatal Cardiovascular morbidity
The proportion of subjects who experience other non-fatal cardiovascular morbidity such as recurrent myocardial infarction, ventricular arrhythmia and CVA
Measured: 6 months
Safety and Tolerability - Rate of Discontinuation
Rate of discontinuation of therapy due to side effects
Measured: 6 months
Safety and Tolerability - Severe Side Effects
Rate of severe side effects requiring hospitalization, extension of length-of-stay.
Measured: 6 months
Safety and Tolerability - Reversibility of Side Effects without Treatment
Percentage of Reversible of Side Effects without treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start8 Nov 2022
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial Infarction Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 89 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rohan Dharmakumar
- Sponsor type
- University, hospital or other
- Collaborators
- Minneapolis Heart Institute, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Rohan Dharmakumar, Indiana University
- Investigators
- Keyur P Vora, MD FACP FACC, Principal investigator, Medical Imaging Research Institute, Indiana University School of MedicineRohan Dharmakumar, PhD, Principal investigator, Medical Imaging Research Institute, Indiana University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604131
- Sponsor's protocol ID
- 13487
- Other IDs
- 2R01HL133407-05
- Acronym
- MIRON-DFP
- Status last verified
- Aug 2026
- First submitted
- 7 Oct 2022
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kali A, Kumar A, Cokic I, Tang RL, Tsaftaris SA, Friedrich MG, Dharmakumar R. Chronic manifestation of postreperfusion intramyocardial hemorrhage as regional iron deposition: a cardiovascular magnetic resonance study with ex vivo validation. Circ Cardiovasc Imaging. 2013 Mar 1;6(2):218-28. doi: 10.1161/CIRCIMAGING.112.000133. Epub 2013 Feb 12.
PubMed 23403335Kali A, Cokic I, Tang R, Dohnalkova A, Kovarik L, Yang HJ, Kumar A, Prato FS, Wood JC, Underhill D, Marban E, Dharmakumar R. Persistent Microvascular Obstruction After Myocardial Infarction Culminates in the Confluence of Ferric Iron Oxide Crystals, Proinflammatory Burden, and Adverse Remodeling. Circ Cardiovasc Imaging. 2016 Nov;9(11):e004996. doi: 10.1161/CIRCIMAGING.115.004996.
PubMed 27903536Wang G, Yang HJ, Kali A, Cokic I, Tang R, Xie G, Yang Q, Francis J, Li S, Dharmakumar R. Influence of Myocardial Hemorrhage on Staging of Reperfused Myocardial Infarctions With T2 Cardiac Magnetic Resonance Imaging: Insights Into the Dependence on Infarction Type With Ex Vivo Validation. JACC Cardiovasc Imaging. 2019 Apr;12(4):693-703. doi: 10.1016/j.jcmg.2018.01.018. Epub 2018 Apr 18.
PubMed 29680356Liu T, Howarth AG, Chen Y, Nair AR, Yang HJ, Ren D, Tang R, Sykes J, Kovacs MS, Dey D, Slomka P, Wood JC, Finney R, Zeng M, Prato FS, Francis J, Berman DS, Shah PK, Kumar A, Dharmakumar R. Intramyocardial Hemorrhage and the "Wave Front" of Reperfusion Injury Compromising Myocardial Salvage. J Am Coll Cardiol. 2022 Jan 4;79(1):35-48. doi: 10.1016/j.jacc.2021.10.034.
PubMed 34991787Dharmakumar R. "Rusty Hearts": Is It Time to Rethink Iron Chelation Therapies in Post-Myocardial-Infarction Setting? Circ Cardiovasc Imaging. 2016 Oct;9(10):e005541. doi: 10.1161/CIRCIMAGING.116.005541. No abstract available.
PubMed 27894072Dharmakumar R. Colors of Myocardial Infarction: Can They Predict the Future? Circ Cardiovasc Imaging. 2017 Dec;10(12):e007291. doi: 10.1161/CIRCIMAGING.117.007291. No abstract available.
PubMed 29242241Dharmakumar R, Nair AR, Kumar A, Francis J. Myocardial Infarction and the Fine Balance of Iron. JACC Basic Transl Sci. 2021 Jul 26;6(7):581-583. doi: 10.1016/j.jacbts.2021.06.004. eCollection 2021 Jul.
PubMed 34368506Guan X, Chen Y, Yang HJ, Zhang X, Ren D, Sykes J, Butler J, Han H, Zeng M, Prato FS, Dharmakumar R. Assessment of intramyocardial hemorrhage with dark-blood T2*-weighted cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2021 Jul 15;23(1):88. doi: 10.1186/s12968-021-00787-4.
PubMed 34261494Chen Y, Ren D, Guan X, Yang HJ, Liu T, Tang R, Ho H, Jin H, Zeng M, Dharmakumar R. Quantification of myocardial hemorrhage using T2* cardiovascular magnetic resonance at 1.5T with ex-vivo validation. J Cardiovasc Magn Reson. 2021 Sep 30;23(1):104. doi: 10.1186/s12968-021-00779-4.
PubMed 34587984Kali A, Tang RL, Kumar A, Min JK, Dharmakumar R. Detection of acute reperfusion myocardial hemorrhage with cardiac MR imaging: T2 versus T2. Radiology. 2013 Nov;269(2):387-95. doi: 10.1148/radiology.13122397. Epub 2013 Jul 11.
PubMed 23847253Cokic I, Kali A, Yang HJ, Yee R, Tang R, Tighiouart M, Wang X, Jackman WS, Chugh SS, White JA, Dharmakumar R. Iron-Sensitive Cardiac Magnetic Resonance Imaging for Prediction of Ventricular Arrhythmia Risk in Patients With Chronic Myocardial Infarction: Early Evidence. Circ Cardiovasc Imaging. 2015 Aug;8(8):10.1161/CIRCIMAGING.115.003642 e003642. doi: 10.1161/CIRCIMAGING.115.003642.
PubMed 26259581Cokic I, Kali A, Wang X, Yang HJ, Tang RL, Thajudeen A, Shehata M, Amorn AM, Liu E, Stewart B, Bennett N, Harlev D, Tsaftaris SA, Jackman WM, Chugh SS, Dharmakumar R. Iron deposition following chronic myocardial infarction as a substrate for cardiac electrical anomalies: initial findings in a canine model. PLoS One. 2013 Sep 16;8(9):e73193. doi: 10.1371/journal.pone.0073193. eCollection 2013.
PubMed 24066038Nair AR, Johnson EA, Yang HJ, Cokic I, Francis J, Dharmakumar R. Reperfused hemorrhagic myocardial infarction in rats. PLoS One. 2020 Dec 2;15(12):e0243207. doi: 10.1371/journal.pone.0243207. eCollection 2020.
PubMed 33264359
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac MRI-guided Deferiprone Therapy for Acute Myocardial Infarction Patients
- ClinicalTrials.gov ID
- NCT05604131
- Acronym / sponsor ID
- MIRON-DFP / 13487
- Conditions
- Acute Myocardial Infarction Type 1
- Keywords
- Acute Myocardial Infarction, Intramyocardial Hemorrhage, Deferiprone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 89 participants (estimated)
- Lead sponsor
- Rohan DharmakumarUniversity, hospital or other
- Collaborators
- Minneapolis Heart Institute, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 3 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with newly diagnosed STEMI (ST-segment elevation myocardial infarction) who appear to meet eligibility criteria will be recruited for participation. Those who agree to participate and are confirmed to be eligible will undergo a cardiac MRI scan and will be randomized to take either deferiprone or placebo daily for 60 days. Total study participation will last 6 months, during which study participants will attend 7 study visits for blood draws, ECGs, and a repeat cardiac MRI at Day 180.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hemorrhagic Myocardial Infarction - Deferiprone | Active comparator | Drug: Deferiprone TabletsEnrolled patients with CMR confirmed presence of intramyocardial hemorrhage |
| Non-hemorrhagic Myocardial Infarction - Deferiprone | Active comparator | Drug: Deferiprone TabletsEnrolled patients with CMR confirmed absence of intramyocardial hemorrhage |
| Hemorrhagic Myocardial Infarction - Placebo | Placebo comparator | Drug: PlaceboEnrolled patients with CMR confirmed presence of intramyocardial hemorrhage |
| Non-hemorrhagic Myocardial Infarction - Placebo | Placebo comparator | Drug: PlaceboEnrolled patients with CMR confirmed absence of intramyocardial hemorrhage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years of age
- Index Anterior wall STEMI
- Emergency coronary angiogram with primary PCI
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deferiprone TabletsDeferiprone 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. | Drug | Hemorrhagic Myocardial Infarction - Deferiprone, Non-hemorrhagic Myocardial Infarction - Deferiprone |
| PlaceboDeferiprone placebo is the non-medicated formulation for a control arm of the study groups. | Drug | Hemorrhagic Myocardial Infarction - Placebo, Non-hemorrhagic Myocardial Infarction - Placebo |
Primary outcome
Treatment Efficacy
Time frame: 6 months
Percentage reduction of hemorrhagic zone iron content by cardiac magnetic resonance at 6 months relative to baseline
5 secondary outcomes
Treatment Effect: Clinical Outcomes of Acute Heart Failure
Time frame: 6 months
Treatment Effect: Clinical Outcomes of Non-Fatal Cardiovascular morbidity
Time frame: 6 months
Safety and Tolerability - Rate of Discontinuation
Time frame: 6 months
Safety and Tolerability - Severe Side Effects
Time frame: 6 months
Safety and Tolerability - Reversibility of Side Effects without Treatment
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Background: PubMed 23403335Kali A, Kumar A, Cokic I, Tang RL, Tsaftaris SA, Friedrich MG, Dharmakumar R. Chronic manifestation of postreperfusion intramyocardial hemorrhage as regional iron deposition: a cardiovascular magnetic resonance study with ex vivo validation. Circ Cardiovasc Imaging. 2013 Mar 1;6(2):218-28. doi: 10.1161/CIRCIMAGING.112.000133. Epub 2013 Feb 12.
- Background: PubMed 27903536Kali A, Cokic I, Tang R, Dohnalkova A, Kovarik L, Yang HJ, Kumar A, Prato FS, Wood JC, Underhill D, Marban E, Dharmakumar R. Persistent Microvascular Obstruction After Myocardial Infarction Culminates in the Confluence of Ferric Iron Oxide Crystals, Proinflammatory Burden, and Adverse Remodeling. Circ Cardiovasc Imaging. 2016 Nov;9(11):e004996. doi: 10.1161/CIRCIMAGING.115.004996.
- Background: PubMed 29680356Wang G, Yang HJ, Kali A, Cokic I, Tang R, Xie G, Yang Q, Francis J, Li S, Dharmakumar R. Influence of Myocardial Hemorrhage on Staging of Reperfused Myocardial Infarctions With T2 Cardiac Magnetic Resonance Imaging: Insights Into the Dependence on Infarction Type With Ex Vivo Validation. JACC Cardiovasc Imaging. 2019 Apr;12(4):693-703. doi: 10.1016/j.jcmg.2018.01.018. Epub 2018 Apr 18.
- Background: PubMed 34991787Liu T, Howarth AG, Chen Y, Nair AR, Yang HJ, Ren D, Tang R, Sykes J, Kovacs MS, Dey D, Slomka P, Wood JC, Finney R, Zeng M, Prato FS, Francis J, Berman DS, Shah PK, Kumar A, Dharmakumar R. Intramyocardial Hemorrhage and the "Wave Front" of Reperfusion Injury Compromising Myocardial Salvage. J Am Coll Cardiol. 2022 Jan 4;79(1):35-48. doi: 10.1016/j.jacc.2021.10.034.
- Background: PubMed 27894072Dharmakumar R. "Rusty Hearts": Is It Time to Rethink Iron Chelation Therapies in Post-Myocardial-Infarction Setting? Circ Cardiovasc Imaging. 2016 Oct;9(10):e005541. doi: 10.1161/CIRCIMAGING.116.005541. No abstract available.
- Background: PubMed 29242241Dharmakumar R. Colors of Myocardial Infarction: Can They Predict the Future? Circ Cardiovasc Imaging. 2017 Dec;10(12):e007291. doi: 10.1161/CIRCIMAGING.117.007291. No abstract available.
- Background: PubMed 34368506Dharmakumar R, Nair AR, Kumar A, Francis J. Myocardial Infarction and the Fine Balance of Iron. JACC Basic Transl Sci. 2021 Jul 26;6(7):581-583. doi: 10.1016/j.jacbts.2021.06.004. eCollection 2021 Jul.
- Background: PubMed 34261494Guan X, Chen Y, Yang HJ, Zhang X, Ren D, Sykes J, Butler J, Han H, Zeng M, Prato FS, Dharmakumar R. Assessment of intramyocardial hemorrhage with dark-blood T2*-weighted cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2021 Jul 15;23(1):88. doi: 10.1186/s12968-021-00787-4.
- Background: PubMed 34587984Chen Y, Ren D, Guan X, Yang HJ, Liu T, Tang R, Ho H, Jin H, Zeng M, Dharmakumar R. Quantification of myocardial hemorrhage using T2* cardiovascular magnetic resonance at 1.5T with ex-vivo validation. J Cardiovasc Magn Reson. 2021 Sep 30;23(1):104. doi: 10.1186/s12968-021-00779-4.
- Background: PubMed 23847253Kali A, Tang RL, Kumar A, Min JK, Dharmakumar R. Detection of acute reperfusion myocardial hemorrhage with cardiac MR imaging: T2 versus T2. Radiology. 2013 Nov;269(2):387-95. doi: 10.1148/radiology.13122397. Epub 2013 Jul 11.
- Background: PubMed 26259581Cokic I, Kali A, Yang HJ, Yee R, Tang R, Tighiouart M, Wang X, Jackman WS, Chugh SS, White JA, Dharmakumar R. Iron-Sensitive Cardiac Magnetic Resonance Imaging for Prediction of Ventricular Arrhythmia Risk in Patients With Chronic Myocardial Infarction: Early Evidence. Circ Cardiovasc Imaging. 2015 Aug;8(8):10.1161/CIRCIMAGING.115.003642 e003642. doi: 10.1161/CIRCIMAGING.115.003642.
- Background: PubMed 24066038Cokic I, Kali A, Wang X, Yang HJ, Tang RL, Thajudeen A, Shehata M, Amorn AM, Liu E, Stewart B, Bennett N, Harlev D, Tsaftaris SA, Jackman WM, Chugh SS, Dharmakumar R. Iron deposition following chronic myocardial infarction as a substrate for cardiac electrical anomalies: initial findings in a canine model. PLoS One. 2013 Sep 16;8(9):e73193. doi: 10.1371/journal.pone.0073193. eCollection 2013.
- CARDIO-THERANOSTICS is developing diagnostics and therapeutics for hemorrhagic myocardial infarctionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Keyur P Vora, MD FACP FACC principal investigator
Medical Imaging Research Institute, Indiana University School of Medicine
Rohan Dharmakumar, PhD principal investigator
Medical Imaging Research Institute, Indiana University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Deferiprone Tablets in people with Acute Myocardial Infarction Type 1, run by Rohan Dharmakumar at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Research Coordinator ((317) 274-0985, csaha@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Efficacy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05604131, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.