Ferric Carboximaltose on Intra-myocardial Iron Load in Patients With Heart Failure

NCT03871699 | Unknown Phase 4 FDA Drug

• 1 other identifier: IronHeart
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Cardiac Failure; Systolic Heart Failure; Heart Failure, Systolic

Keywords

Heart; Failure; Iron; Deficiency; Systolic; Reduced; Ejection

Outcome Measures

Primary Outcomes (1)

• Absolut changes in left ventricular ejection fraction

  Compare the left ventricular ejection fraction 30 days after receiving 1g of ferric carboxymaltose intravenously.

  30 days

Study Arms (1)

Iron Reposition

EXPERIMENTAL

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

Interventions

Ferric carboxymaltose DRUG

Administration of Ferric Carboxymaltose intravenously, one dose only.

Also known as: Ferrinject

Iron Reposition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Left ventricular ejection fraction \<40% assessed by transthoracic echocardiography or cardiac magnetic resonance with at least 3 months.
• Serum ferritin \< 100µg/L or 100-299µg/L with transferrin saturation \< 20%
• clinical stability during last 3 months

You may not qualify if:

• Use of intracardiac defibrillator or pacemaker.
• Severe to moderate valvar heart disease
• Clinical instability, acute coronary syndrome and cardiac surgery within 3 months.

Sponsors & Collaborators

• Hospital Moinhos de Vento: lead
• Takeda: collaborator

Study Sites (1)

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90440050, Brazil

Location

MeSH Terms

Conditions

Heart Failure; Heart Failure, Systolic; Systolic Murmurs

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Murmurs; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Luis Beck da Silva, MD ScD

  Hospital Moinhos de Vento

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Central Study Contacts

Luis Beck da Silva, MD ScD

CONTACT

+5551997330870; luisbeckdasilva@gmail.com

Luciano Giordani, MD

CONTACT

lucianogiordani@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2019
• First Posted: March 12, 2019
• Study Start: August 30, 2019
• Primary Completion: December 31, 2020
• Study Completion: February 28, 2021
• Last Updated: July 12, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)