Ferric Carboxymaltose in Heart Failure With Iron Deficiency - HEART-FID

Aug 26, 2023
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Trial Sponsor:
American Regent, a Daiichi Sankyo Group company
Date Presented:
08/26/2023
Date Published:
08/26/2023
Original Posted Date:
08/26/2023
References

Contribution To Literature:

The HEART-FID trial showed that IV ferric carboxymaltose may be associated with a modest improvement in cardiovascular outcomes compared with placebo.

Description:

The goal of the trial was to evaluate intravenous (IV) ferric carboxymaltose compared with placebo among ambulatory patients with chronic systolic heart failure.

Study Design

  • Randomized
  • Parallel
  • Double-blind

Ambulatory patients with chronic systolic heart failure were randomized to IV ferric carboxymaltose (n = 1,532) vs. placebo (n = 1,533), in addition to usual therapy for heart failure.

  • Total number of enrollees: 3,065
  • Duration of follow-up: median 1.9 years
  • Mean patient age: 69 years
  • Percentage female: 33%

Inclusion criteria:

  • Age ≥18 years
  • Chronic systolic heart failure (LVEF ≤40%)
  • Hemoglobin level >9.0 g/dL and either <13.5 g/dL (in women) or <15.0 g/dL (in men)
  • Iron deficiency (ferritin level <100 ng/mL or 100-300 ng/mL with transferrin saturation <20%)
  • Heart failure hospitalization within past 12 months or elevated natriuretic peptide level

Principal Findings:

The primary hierarchical composite outcome (death, hospitalization for heart failure, and 6-minute walk distance) was marginally improved with IV ferric carboxymaltose vs. placebo (p = 0.019; the p value for significance was set at <0.01). Overall win ratio was 1.10 (0.99 to 1.23).

  • All-cause mortality: 8.6% with IV ferric carboxymaltose vs. 10.3% with placebo
  • Heart failure hospitalizations: 13.3% with IV ferric carboxymaltose vs. 14.8% with placebo
  • Change in 6-minute walk distance: 8 m with IV ferric carboxymaltose vs. 4 m with placebo

Secondary outcomes:

  • Time to cardiovascular death or heart failure hospitalization: 31.0% with IV ferric carboxymaltose vs. 32.2% with placebo (p = not significant)
  • Treatment-emergent adverse events: 27.0% with IV ferric carboxymaltose vs. 26.2% with placebo

Interpretation:

Among patients with chronic systolic heart failure and iron deficiency, IV ferric carboxymaltose was associated with a marginal improvement in cardiovascular outcomes compared with placebo. IV ferric carboxymaltose appeared to be safe. Further research on the topic appears warranted.

References:

Mentz RJ, Garg J, Rockhold FW, et al., on behalf of the HEART-FID Investigators. Ferric Carboxymaltose in Heart Failure With Iron Deficiency. N Engl J Med 2023;389:975-86.

Editorial: Martens P, Mullens W. Treating Iron Deficiency in Heart Failure. N Engl J Med 2023;389:1041-2.

Presented by Dr. Robert Mentz at the European Society of Cardiology Congress, Amsterdam, Netherlands, August 26, 2023.

Clinical Topics: Dyslipidemia, Heart Failure and Cardiomyopathies, Lipid Metabolism, Acute Heart Failure

Keywords: Anemia, Iron-Deficiency, ESC Congress, ESC23, Ferric Compounds, Ferritins, Heart Failure


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