NCT03871699: IronHeart

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

Status unknown Phase 4 Last updated 12 July 2019

What this trial tests

Phase 4 trial testing Ferric carboxymaltose in Cardiac Failure in 20 participants. Status unknown.

Timeline

30 August 2019

Primary endpoint
31 December 2020

28 February 2021

Quick facts

Lead sponsor	Hospital Moinhos de Vento
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	30 August 2019
Primary completion	31 December 2020
Estimated completion	28 February 2021
Sites	1 location across Brazil

Drugs / interventions tested

• Ferric carboxymaltose (FERRIC CARBOXYMALTOSE) — full drug profile →

Conditions studied

• Cardiac Failure — all drugs for Cardiac Failure →
• Systolic Heart Failure — all drugs for Systolic Heart Failure →
• Heart Failure, Systolic — all drugs for Heart Failure, Systolic →

Sponsor

Hospital Moinhos de Vento

Who can join

18 and older, any sex, with Cardiac Failure or Systolic Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.