Randomized Placebo-Controlled Trial of Ferric Carboxymaltose in Heart Failure With Iron Deficiency: Rationale and...

Area of Science:

• Cardiology
• Internal Medicine
• Pharmacology

Background:

• Iron deficiency (ID) affects 40-50% of heart failure (HF) patients with reduced ejection fraction (HFrEF).
• ID in HFrEF is associated with worse prognosis and limited data on morbidity and mortality benefits of treatment.
• Intravenous ferric carboxymaltose has shown promise in improving patient-reported outcomes and functional capacity in prior studies.

Purpose of the Study:

• To evaluate the efficacy and safety of ferric carboxymaltose versus placebo in symptomatic HFrEF patients with ID.
• To assess the impact of ferric carboxymaltose on primary endpoints including death, HF hospitalization, and functional capacity.

Main Methods:

• HEART-FID is a multicenter, randomized, double-blind, placebo-controlled trial.
• Enrollment of approximately 3014 patients aged ≥18 years with stable chronic HFrEF (NYHA class II-IV, EF ≤40%) and ID.
• Primary endpoint: hierarchical composite of death and HF hospitalization at 12 months, and change in 6-minute walk test distance at 6 months.

Main Results:

• Data on main results are not yet available as the trial is ongoing.
• The study is designed to provide robust data on the clinical impact of ferric carboxymaltose in this population.
• Interim analyses may provide preliminary insights into treatment effects.

Conclusions:

• The HEART-FID trial will clarify the role of long-term intravenous ferric carboxymaltose in ambulatory HFrEF patients with ID.
• Findings will inform clinical practice regarding the addition of ferric carboxymaltose to standard care.
• The study aims to provide evidence for improved clinical outcomes in this vulnerable patient group.