Ferric Carboximaltose on Intra-myocardial Iron Load in Patients With Heart Failure (IronHeart)
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|ClinicalTrials.gov Identifier: NCT03871699|
Recruitment Status : Not yet recruiting
First Posted : March 12, 2019
Last Update Posted : July 12, 2019
In general, anemia is associated with a greater presence of HF symptoms, worsening NYHA functional class, higher rate of hospitalization for heart failure, and reduced survival. However, it is unclear whether anemia is the cause of decreased survival or a marker for more advanced disease. Correction of iron deficiency in patients with New York Heart Association (NYHA) class II or III HF using intravenous iron (Ferinject®) improved "overall patient self-assessment" and NYHA functional class of 6-minute walk and health-related quality of life) in the FAIR-HF trial.
It is unknown if iron deficiency is correlated with intra-myocardial iron load as assessed by cardiac magnetic resonance (CMR) and if the treatment with intravenous iron has any impact on intra-myocardial iron load and left ventricular function.
The aim of the present study is to evaluate the effect of intravenous iron replacement on intra-myocardial iron deposits and the effect on left ventricular function.
Because it is a pilot study with few data in the literature, it is planned to use an initial sample of 20 patients.
We aim to evaluate the global ventricular function, the iron load by the T2 * method, the cardiac strain, the "Fiddle" and the "Fat water" of each patient by CMR. After this examination, patients will undergo intravenous infusion of 1g of Ferric Carboxymaltose (Ferinject®).
A comparative analysis of the ejection fraction values at the beginning and at the end of the study by CMR will be performed, in addition to a clinical reassessment.
The inclusion criteria will be: Patients older than 18 years, with iron deficiency and reduced ejection fraction defined as: serum ferritin <100 μg / L or with ferritin 100-299 μg / L with transferrin saturation <20 %; Hemoglobin <12g / dL in women and <13g / dL in men; Clinical stability in the last 3 months; Left ventricular ejection fraction (LVEF) <40% assessed by transthoracic echocardiography or CMR in the last 3 months. The exclusion criteria will be: patients with preserved ejection fraction (> 50%), pregnant women, refusal to participate in the present study, implantable pacemaker or implantable defibrillator incompatible with MRI, cerebral cerebral aneurysm clip and/or intracerebral or intraocular metal fragments, electronic cochlear implants, patients with claustrophobia, patients with clinical or hemodynamic instability and patients with indication for blood transfusion (Hb ≤ 7g / dL).
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Failure Systolic Heart Failure Heart Failure, Systolic||Drug: Ferric carboxymaltose||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Ferric Carboximaltose on Intra-myocardial Iron Load Assessed by Cardiac Magnetic Resonance in Patients With Heart Failure With Reduced Ejection Fraction (HFREF).|
|Estimated Study Start Date :||August 30, 2019|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||February 28, 2021|
Experimental: Iron Reposition
The selected patients will receive 1g of ferric carboxymaltose applied intravenously after dilution in 100ml of crystalline solution. the infusion time will be around 15 minutes realized at the moinhos the vento infusion center.
Drug: Ferric carboxymaltose
Administration of Ferric Carboxymaltose intravenously, one dose only.
Other Name: Ferrinject
- Absolut changes in left ventricular ejection fraction [ Time Frame: 30 days ]Compare the left ventricular ejection fraction 30 days after receiving 1g of ferric carboxymaltose intravenously.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03871699
|Contact: Luis Beck da Silva, MD ScDemail@example.com|
|Contact: Luciano Giordani, MDfirstname.lastname@example.org|
|Hospital Moinhos de Vento|
|Porto Alegre, RS, Brazil, 90440050|
|Contact: LUIS BECK DA SILVA, MD +5551997330870 email@example.com|
|Contact: CARISI A POLANCZYK, MD +555133143434 CARISI.POLANCZYK@hmv.org.br|
|Principal Investigator: LUIS BECK DA SILVA, MD ScD|
|Principal Investigator:||Luis Beck da Silva, MD ScD||Hospital Moinhos de Vento|
|Study Director:||Luciano Giordani, MD||Hospital Moinhos de Vento|
|Study Director:||Carisi A Polanczyk, MD ScD||Hospital Moinhos de Vento|
|Study Director:||Paulo R Schvartzman, MD ScD||Hospital Moinhos de Vento|