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Eur Heart J. 2015 Mar 14;36(11):657-68. doi: 10.1093/eurheartj/ehu385. Epub 2014 Aug 31.

Beneficial effects of long-term intravenous iron therapy with ferric carboxymaltose in patients with symptomatic heart failure and iron deficiency†.

Author information

1
Department of Heart Diseases, Medical University, Wroclaw, Poland Department of Cardiology, Center for Heart Diseases, Clinical Military Hospital, Weigla 5 53-114, Wroclaw, Poland piotrponikowski@4wsk.pl.
2
Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
3
Heart Diseases Biomedical Research Group, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.
4
Department of Internal Medicine I, University Hospital Würzburg, Würzburg, Germany Comprehensive Heart Failure Center, University of Würzburg, Würzburg, Germany.
5
CHU Pitié-Salpêtrière, Institut de Cardiologie, Paris, France.
6
Lomonosov Moscow State University, Moscow, Russia.
7
Department of Cardiology, King's College Hospital, Denmark Hill, London SE5 9RS, UK.
8
Ukranian Strazhesko Institute of Cardiology, 5, Narodnoko Opolchenia St, Kiev 03151, Ukraine.
9
Maria Cecilia Hospital, GVM Care&Research-E.S. Health Science Foundation, Cotignola, Italy.
10
Vifor Pharma, Glattbrugg, Switzerland.
11
Athens University Hospital Attikon, Athens, Greece.
12
Department of Cardiology, University Hospital Zurich, Switzerland.
13
Department of Innovative Clinical Trials, University Medical Centre Göttingen, Göttingen, Germany.

Abstract

AIM:

The aim of this study was to evaluate the benefits and safety of long-term i.v. iron therapy in iron-deficient patients with heart failure (HF).

METHODS AND RESULTS:

CONFIRM-HF was a multi-centre, double-blind, placebo-controlled trial that enrolled 304 ambulatory symptomatic HF patients with left ventricular ejection fraction ≤45%, elevated natriuretic peptides, and iron deficiency (ferritin <100 ng/mL or 100-300 ng/mL if transferrin saturation <20%). Patients were randomized 1 : 1 to treatment with i.v. iron, as ferric carboxymaltose (FCM, n = 152) or placebo (saline, n = 152) for 52 weeks. The primary end-point was the change in 6-min-walk-test (6MWT) distance from baseline to Week 24. Secondary end-points included changes in New York Heart Association (NYHA) class, Patient Global Assessment (PGA), 6MWT distance, health-related quality of life (QoL), Fatigue Score at Weeks 6, 12, 24, 36, and 52 and the effect of FCM on the rate of hospitalization for worsening HF. Treatment with FCM significantly prolonged 6MWT distance at Week 24 (difference FCM vs. placebo: 33 ± 11 m, P = 0.002). The treatment effect of FCM was consistent in all subgroups and was sustained to Week 52 (difference FCM vs. placebo: 36 ± 11 m, P < 0.001). Throughout the study, an improvement in NYHA class, PGA, QoL, and Fatigue Score in patients treated with FCM was detected with statistical significance observed from Week 24 onwards. Treatment with FCM was associated with a significant reduction in the risk of hospitalizations for worsening HF [hazard ratio (95% confidence interval): 0.39 (0.19-0.82), P = 0.009]. The number of deaths (FCM: 12, placebo: 14 deaths) and the incidence of adverse events were comparable between both groups.

CONCLUSION:

Treatment of symptomatic, iron-deficient HF patients with FCM over a 1-year period resulted in sustainable improvement in functional capacity, symptoms, and QoL and may be associated with risk reduction of hospitalization for worsening HF (ClinicalTrials.gov number NCT01453608).

KEYWORDS:

Ferric carboxymaltose; Heart failure; Iron deficiency

PMID:
25176939
PMCID:
PMC4359359
DOI:
10.1093/eurheartj/ehu385
[Indexed for MEDLINE]
Free PMC Article

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