Heart FailurePhase 4NCT03398681

Changes in Myocardial Iron After Iron Administration

A Phase 4 study testing Ferric carboymaltose and Cardiac magnetic resonance in people with Heart Failure and Iron-deficiency, run by Fundación para la Investigación del Hospital Clínico de Valencia at 6 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Failure, Iron-deficiency
What is being tested?: Ferric carboymaltose and Cardiac magnetic resonance
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 53 participants
Where: 6 sitesSpain
Study dates: 1 May 2017to 30 Jul 2018
Phase: Phase 4
Are there results?: None posted in the registry

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

Patients with ambulatory chronic heart failure
Older than 18 years
Patients in NYHA class II-III on optimal background therapy (as determined by the investigator) for at least 4 weeks with no dose changes of HF drugs during the last 2 weeks (with the exception of diuretics)
Elevated natriuretic peptides levels (NT-proBNP >400 pg/ml) at the screening visit
Left ventricle ejection fraction <50% documented in the last 12 months
Iron deficiency defined as: serum ferritin level <100 μg/L or ferritin level 100-299 μg/L when TSAT is less than 20%, and hemoglobin <15 g/dL (all at screening)
Participant is willing and able to give informed consent for participation in the study

Who cannot join

Known sensitivity to any of the products to be administered per protocol.
History of acquired iron overload.
Severe valve disease, or being scheduled for cardiac surgery within the next 30 days.
Acute myocardial infarction or acute coronary syndrome, transient ischemic attack, or stroke within the last 3 months prior to randomization.
Coronary artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, and aortic; diagnostic catheters are allowed), or major surgery, including thoracic and cardiac surgery, within the last 3 months prior to randomization.
Ischemic heart disease scheduled for revascularization procedures within the next 30 days.

Show all 19Show fewer

HF scheduled for cardiac resynchronization therapy within the next 30 days.
Patients with active bleeding in the last 30 days.
Known active infection or active malignancy.
Subject at an immediate need of transfusion or hemoglobin ≥15 g/dL.
Anemia due to reasons other than iron deficiency
Immunosuppressive therapy or renal dialysis
History of erythropoietin, intravenous iron therapy, and blood transfusion in the previous 12 weeks.
Oral iron therapy at doses >100 mg/day in previous 1 week prior to randomization.
Subjects with an immediate need for transfusion.
Pregnant or breastfeeding women.
Subject of childbearing potential who is not willing to use adequate contraceptive precautions during the study and for up to 5 days after the last scheduled dose of study medication.
Subject currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study, or subject is receiving other investigational agent(s).
Any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Spain6 sites

Hospital General de Castellón
Castellon, Castellón
Hospital de Manises
Manises, Valencia
ERESA
Valencia, 46010
Fundación Investigación Hospital Clínico Universitario de Valencia. Instituto de Investigación Sanitaria INCLIVA.
Valencia, 46010
Hospital General de Valencia
Valencia
Hospital la Fe
Valencia

Other trials in Spain

About this study

Official title: Changes in Myocardial Iron Content Following Administration of Intravenous Iron (Myocardial-IRON)

Recent studies have shown that treatment with intravenous iron in patients with iron deficiency (ID) and heart failure with reduced ejection fraction (HFrEF) improves symptomatology, functional capacity, quality of life, and decreases hospitalizations regardless of anemia. In addition, a decrease in myocardial iron content has been observed in patients with chronic HFrEF. This preliminary evidence has led to postulate that myocardial iron deficiency could play a direct role in the pathogenesis and progression of the disease.

The investigators hypothesize that the repletion of myocardial iron would explain part of the benefit of this treatment. Thus, the investigators postulate that cardiac magnetic resonance (CMR) (T2* and T1-mapping sequences) will be sensible enough to detect changes in myocardial iron content as a result of intravenous iron administration, and that such changes will correlate with simultaneous changes in parameters of heart failure severity.

In this double-blind 1:1 randomized study controlled by placebo the investigators aim to determine the changes in myocardial iron content after treatment with intravenous ferric carboxymaltose (FCM) by CMR at 7 and 30 days in patients with stable HFrEF and ID.

Conditions: Heart Failure, Iron-deficiency
Being tested: Ferric carboymaltose, Placebo (Normal saline), Cardiac magnetic resonance
Keywords: Heart failure, Iron deficiency, Cardiac magnetic resonance, Ferric carboxymaltose, Myocardial iron
Medical subject headings: Heart Failure, Anemia, Iron-Deficiency, Iron Deficiencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ferric carboymaltoseDrug
Also called Ferinject, intravenous iron
Ferric Carboxymaltose solution [Ferinject® (FCM), Vifor Pharma (Glattbrugg, Switzerland)]
Placebo (Normal saline)Drug
Normal saline (0.9% weight/volume (w/v) NaCl)
Cardiac magnetic resonanceDiagnostic test
Cardiac magnetic resonance including T2* and T1-mapping sequences

Study groups in NCT03398681
Study group	Role	What they receive
Intravenous ferric carboxymaltose	Active comparator	Ferric Carboxymaltose solution [Ferinject® (FCM), Vifor Pharma (Glattbrugg, Switzerland)] will be given as a perfusion of 20 mL (which is the amount of FCM that is equivalent to 1000 mg of iron) diluted in a sterile saline solution (0.9% weight/volume (w/v) NaCl) administered over at least 15 min. Receives: Drug: Ferric carboymaltose; Diagnostic Test: Cardiac magnetic resonance
Normal saline	Placebo comparator	Normal saline (0.9% weight/volume (w/v) NaCl) administered as per the instructions for active therapy. Receives: Drug: Placebo (Normal saline); Diagnostic Test: Cardiac magnetic resonance

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in myocardial iron content assessed by CMR T2*
Measured: 7 and 30 days
Changes in myocardial iron content assessed by CMR T1-mapping
Measured: 7 and 30 days

Secondary outcomes (25)

Changes in left ventricular systolic function evaluated with cardiac magnetic resonance
Changes in left ventricular systolic function evaluated with cardiac magnetic resonance
Measured: 7 and 30 days
6-minute walking test
Changes in functional capacity assessed by distance walked in 6 minutes (6-minute walking test)
Measured: 7 and 30 days
New York Heart Association (NYHA) class.
Changes in functional capacity assessed by New York Heart Association (NYHA) class.
Measured: 7 and 30 days
The Kansas City quality of life questionnaire (KCCQ)
Quality of life assessed by The Kansas City quality of life questionnaire (KCCQ). KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Measured: 7 and 30 days
Antigen carbohydrate 125 (CA125)
Laboratory tests, biomarkers: antigen carbohydrate 125 (CA125)
Measured: 30 days
Amino-terminal pro-brain natriuretic peptide (NT-proBNP)
Laboratory tests, biomarkers: amino-terminal pro-brain natriuretic peptide (NT-proBNP)
Measured: 30 days
Galectin-3
Laboratory tests, biomarkers: galectin-3
Measured: 30 days
ST-2
Laboratory tests, biomarkers: ST-2
Measured: 30 days
High-sensitivity troponin (hsTnT)
Laboratory tests, biomarkers: high-sensitivity troponin (hsTnT)
Measured: 30 days
Cystatin C
Laboratory tests, biomarkers: cystatin C
Measured: 30 days
Neutrophil gelatinase-associated lipocalin (NGAL)
Laboratory tests, biomarkers: neutrophil gelatinase-associated lipocalin (NGAL)
Measured: 30 days
Serum creatinine
Laboratory tests: serum creatinine
Measured: 30 days
Urea
Laboratory tests: urea
Measured: 30 days
Estimated glomerular filtration rate (eGFR)
Laboratory tests: estimated glomerular filtration rate (eGFR)
Measured: 30 days
Hemoglobin
Laboratory tests: hemoglobin
Measured: 30 days
Ferritin
Laboratory tests: ferritin
Measured: 30 days
Transferrin saturation (TSAT)
Laboratory tests: transferrin saturation (TSAT)
Measured: 30 days
soluble transferrin receptor (sTfR)
Laboratory tests: soluble transferrin receptor (sTfR)
Measured: 30 days
Hepcidin
Laboratory tests: hepcidin.
Measured: 30 days
Clinical events: all-cause hospitalizations
All-cause hospitalizations
Measured: 30 days
Clinical events: cardiovascular hospitalizations.
Cardiovascular hospitalizations
Measured: 30 days
Clinical events: heart failure hospitalizations.
Heart failure hospitalizations
Measured: 30 days
Clinical events: time to first hospitalization for any reason.
Time to first hospitalization for any reason.
Measured: 30 days
Clinical events: time to first hospitalization for any cardiovascular reason.
Time to first hospitalization for any cardiovascular reason.
Measured: 30 days
Clinical events: time to first hospitalization due to worsening heart failure.
Time to first hospitalization due to worsening heart failure.
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 201730 Jul 2018

First posted12 Jan 2018
Study start1 May 2017
Primary completion30 Jul 2018
Study completion30 Jul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Heart FailureStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: After providing informed consent, patients will be randomly assigned, with a remote, web-based computer-generated block randomization procedure in an allocation 1:1 ratio, to either receive intravenous ferric carboxymaltose (FCM) or placebo. Intramyocardial iron will be evaluated at 3 time points: before administration of CMF/placebo, and at 7 and 30 days. At 30 days, patients assigned to placebo will receive intravenous CMF if iron deficiency persists.
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03398681
Sponsor's protocol ID: MYOCARDIAL-IRON
Other IDs: 2016-004194-40, 2016
Status last verified: Jul 2019
First submitted: 21 Nov 2017
Last updated: 30 Jul 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Del Canto I, Santas E, Cardells I, Minana G, Palau P, Llacer P, Facila L, Lopez-Vilella R, Almenar L, Bodi V, Lopez-Lereu MP, Monmeneu JV, Sanchis J, Moratal D, Maceira AM, de la Espriella R, Chorro FJ, Bayes-Genis A, Nunez J; Myocardial-IRON Investigators dagger. Short-Term Changes in Left and Right Ventricular Cardiac Magnetic Resonance Feature Tracking Strain Following Ferric Carboxymaltose in Patients With Heart Failure: A Substudy of the Myocardial-IRON Trial. J Am Heart Assoc. 2022 Apr 5;11(7):e022214. doi: 10.1161/JAHA.121.022214. Epub 2022 Mar 18.
PubMed 35301854
Meucci MC, Reinders MEJ, Groeneweg KE, Bezstarosti S, Ajmone Marsan N, Bax JJ, De Fijter JW, Delgado V. Cardiovascular Effects of Autologous Bone Marrow-Derived Mesenchymal Stromal Cell Therapy With Early Tacrolimus Withdrawal in Renal Transplant Recipients: An Analysis of the Randomized TRITON Study. J Am Heart Assoc. 2021 Dec 21;10(24):e023300. doi: 10.1161/JAHA.121.023300. Epub 2021 Dec 16.
PubMed 34913362
Nunez J, Minana G, Cardells I, Palau P, Llacer P, Facila L, Almenar L, Lopez-Lereu MP, Monmeneu JV, Amiguet M, Gonzalez J, Serrano A, Montagud V, Lopez-Vilella R, Valero E, Garcia-Blas S, Bodi V, de la Espriella-Juan R, Lupon J, Navarro J, Gorriz JL, Sanchis J, Chorro FJ, Comin-Colet J, Bayes-Genis A; Myocardial-IRON Investigators* dagger. Noninvasive Imaging Estimation of Myocardial Iron Repletion Following Administration of Intravenous Iron: The Myocardial-IRON Trial. J Am Heart Assoc. 2020 Feb 18;9(4):e014254. doi: 10.1161/JAHA.119.014254. Epub 2020 Feb 13.
PubMed 32067585
Minana G, Cardells I, Palau P, Llacer P, Facila L, Almenar L, Lopez-Lereu MP, Monmeneu JV, Amiguet M, Gonzalez J, Serrano A, Montagud V, Lopez-Vilella R, Valero E, Garcia-Blas S, Bodi V, de la Espriella-Juan R, Sanchis J, Chorro FJ, Bayes-Genis A, Nunez J; Myocardial-IRON Investigators. Changes in myocardial iron content following administration of intravenous iron (Myocardial-IRON): Study design. Clin Cardiol. 2018 Jun;41(6):729-735. doi: 10.1002/clc.22956. Epub 2018 Jun 5.
PubMed 29607528

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Changes in Myocardial Iron Content Following Administration of Intravenous Iron (Myocardial-IRON)
ClinicalTrials.gov ID: NCT03398681
Acronym / sponsor ID: MYOCARDIAL-IRON
Conditions: Heart Failure, Iron-deficiency
Keywords: Heart failure, Iron deficiency, Cardiac magnetic resonance, Ferric carboxymaltose, Myocardial iron
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
Study start: 1 May 2017 (actual)
Primary completion: 30 Jul 2018 (actual)
Study completion: 30 Jul 2018 (actual)
First posted: 12 Jan 2018 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
Model description: After providing informed consent, patients will be randomly assigned, with a remote, web-based computer-generated block randomization procedure in an allocation 1:1 ratio, to either receive intravenous ferric carboxymaltose (FCM) or placebo. Intramyocardial iron will be evaluated at 3 time points: before administration of CMF/placebo, and at 7 and 30 days. At 30 days, patients assigned to placebo will receive intravenous CMF if iron deficiency persists.

Arm	Type	Receives
Intravenous ferric carboxymaltose	Active comparator	Drug: Ferric carboymaltose, Diagnostic Test: Cardiac magnetic resonanceFerric Carboxymaltose solution [Ferinject® (FCM), Vifor Pharma (Glattbrugg, Switzerland)] will be given as a perfusion of 20 mL (which is the amount of FCM that is equivalent to 1000 mg of iron) diluted in a sterile saline solution (0.9% weight/volume (w/v) NaCl) administered over at least 15 min.
Normal saline	Placebo comparator	Drug: Placebo (Normal saline), Diagnostic Test: Cardiac magnetic resonanceNormal saline (0.9% weight/volume (w/v) NaCl) administered as per the instructions for active therapy.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Patients with ambulatory chronic heart failure
Older than 18 years
Patients in NYHA class II-III on optimal background therapy (as determined by the investigator) for at least 4 weeks with no dose changes of HF drugs during the last 2 weeks (with the exception of diuretics)
Elevated natriuretic peptides levels (NT-proBNP >400 pg/ml) at the screening visit
Left ventricle ejection fraction <50% documented in the last 12 months

Key exclusion criteria (19 listed)

Known sensitivity to any of the products to be administered per protocol.
History of acquired iron overload.
Severe valve disease, or being scheduled for cardiac surgery within the next 30 days.
Acute myocardial infarction or acute coronary syndrome, transient ischemic attack, or stroke within the last 3 months prior to randomization.
Coronary artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, and aortic; diagnostic catheters are allowed), or major surgery, including thoracic and cardiac surgery, within the last 3 months prior to randomization.

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
Ferric carboymaltoseAlso: Ferinject, intravenous ironFerric Carboxymaltose solution [Ferinject® (FCM), Vifor Pharma (Glattbrugg, Switzerland)]	Drug	Intravenous ferric carboxymaltose
Placebo (Normal saline)Normal saline (0.9% weight/volume (w/v) NaCl)	Drug	Normal saline
Cardiac magnetic resonanceCardiac magnetic resonance including T2* and T1-mapping sequences	Diagnostic test	Intravenous ferric carboxymaltose, Normal saline

Primary outcome

Changes in myocardial iron content assessed by CMR T2*
Time frame: 7 and 30 days
Changes in myocardial iron content assessed by CMR T1-mapping
Time frame: 7 and 30 days

25 secondary outcomes

Changes in left ventricular systolic function evaluated with cardiac magnetic resonance
Time frame: 7 and 30 days
6-minute walking test
Time frame: 7 and 30 days
New York Heart Association (NYHA) class.
Time frame: 7 and 30 days
The Kansas City quality of life questionnaire (KCCQ)
Time frame: 7 and 30 days
Antigen carbohydrate 125 (CA125)
Time frame: 30 days
Amino-terminal pro-brain natriuretic peptide (NT-proBNP)
Time frame: 30 days
Galectin-3
Time frame: 30 days
ST-2
Time frame: 30 days
High-sensitivity troponin (hsTnT)
Time frame: 30 days
Cystatin C
Time frame: 30 days
Neutrophil gelatinase-associated lipocalin (NGAL)
Time frame: 30 days
Serum creatinine
Time frame: 30 days
Urea
Time frame: 30 days
Estimated glomerular filtration rate (eGFR)
Time frame: 30 days
Hemoglobin
Time frame: 30 days
Ferritin
Time frame: 30 days
Transferrin saturation (TSAT)
Time frame: 30 days
soluble transferrin receptor (sTfR)
Time frame: 30 days
Hepcidin
Time frame: 30 days
Clinical events: all-cause hospitalizations
Time frame: 30 days
Clinical events: cardiovascular hospitalizations.
Time frame: 30 days
Clinical events: heart failure hospitalizations.
Time frame: 30 days
Clinical events: time to first hospitalization for any reason.
Time frame: 30 days
Clinical events: time to first hospitalization for any cardiovascular reason.
Time frame: 30 days
Clinical events: time to first hospitalization due to worsening heart failure.
Time frame: 30 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
Derived from this study: PubMed 35301854Del Canto I, Santas E, Cardells I, Minana G, Palau P, Llacer P, Facila L, Lopez-Vilella R, Almenar L, Bodi V, Lopez-Lereu MP, Monmeneu JV, Sanchis J, Moratal D, Maceira AM, de la Espriella R, Chorro FJ, Bayes-Genis A, Nunez J; Myocardial-IRON Investigators dagger. Short-Term Changes in Left and Right Ventricular Cardiac Magnetic Resonance Feature Tracking Strain Following Ferric Carboxymaltose in Patients With Heart Failure: A Substudy of the Myocardial-IRON Trial. J Am Heart Assoc. 2022 Apr 5;11(7):e022214. doi: 10.1161/JAHA.121.022214. Epub 2022 Mar 18.
Derived from this study: PubMed 34913362Meucci MC, Reinders MEJ, Groeneweg KE, Bezstarosti S, Ajmone Marsan N, Bax JJ, De Fijter JW, Delgado V. Cardiovascular Effects of Autologous Bone Marrow-Derived Mesenchymal Stromal Cell Therapy With Early Tacrolimus Withdrawal in Renal Transplant Recipients: An Analysis of the Randomized TRITON Study. J Am Heart Assoc. 2021 Dec 21;10(24):e023300. doi: 10.1161/JAHA.121.023300. Epub 2021 Dec 16.
Derived from this study: PubMed 32067585Nunez J, Minana G, Cardells I, Palau P, Llacer P, Facila L, Almenar L, Lopez-Lereu MP, Monmeneu JV, Amiguet M, Gonzalez J, Serrano A, Montagud V, Lopez-Vilella R, Valero E, Garcia-Blas S, Bodi V, de la Espriella-Juan R, Lupon J, Navarro J, Gorriz JL, Sanchis J, Chorro FJ, Comin-Colet J, Bayes-Genis A; Myocardial-IRON Investigators* dagger. Noninvasive Imaging Estimation of Myocardial Iron Repletion Following Administration of Intravenous Iron: The Myocardial-IRON Trial. J Am Heart Assoc. 2020 Feb 18;9(4):e014254. doi: 10.1161/JAHA.119.014254. Epub 2020 Feb 13.
Derived from this study: PubMed 29607528Minana G, Cardells I, Palau P, Llacer P, Facila L, Almenar L, Lopez-Lereu MP, Monmeneu JV, Amiguet M, Gonzalez J, Serrano A, Montagud V, Lopez-Vilella R, Valero E, Garcia-Blas S, Bodi V, de la Espriella-Juan R, Sanchis J, Chorro FJ, Bayes-Genis A, Nunez J; Myocardial-IRON Investigators. Changes in myocardial iron content following administration of intravenous iron (Myocardial-IRON): Study design. Clin Cardiol. 2018 Jun;41(6):729-735. doi: 10.1002/clc.22956. Epub 2018 Jun 5.

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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. This study is not recruiting at the moment.

Julio Nuñez, MD PhD principal investigator

Fundación Investigación Hospital Clínico Universitario de Valencia. Instituto de Investigación Sanitaria INCLIVA.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 19 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: finished, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in myocardial iron content assessed by CMR T2* (time frame: 7 and 30 days). The study lists 2 primary outcomes in all. 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 NCT03398681, which also lists 4 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 30 Jul 2019.