Abstract
AimThe 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 resultsCONFIRM-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.ConclusionTreatment 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).
Highlights
With the constantly increasing prevalence and incidence, heart failure (HF) has become an epidemic problem carrying relevant medical, social and economic consequences.[1]
Several chronic disorders may be complicated by Iron deficiency (ID),[6,7,8,9] but only recently ID has been reported as a frequent co-morbidity in stable HF patients regardless of ejection fraction[10,11,12] and in patients admitted to hospital due to worsening HF.[13]
We designed the CONFIRM-HF (Ferric CarboxymaltOse evaluatioN on perFormance in patients with IRon deficiency in coMbination with chronic Heart Failure) to address these questions
Summary
With the constantly increasing prevalence and incidence, heart failure (HF) has become an epidemic problem carrying relevant medical, social and economic consequences.[1] Despite recent developments in HF management, the morbidity and mortality in this clinical syndrome remain unacceptably high and many patients suffer from debilitating symptoms adversely affecting their quality of life.[2,3,4] Cardiovascular and non-cardiovascular co-morbidities often complicate the natural course of HF with deleterious impact on clinical status, symptoms, and HF progression, constituting targets for potential intervention.[2,5]. While i.v. iron therapy in iron-deficient stable HF patients[14,16] appears beneficial, there are still uncertainties on the appropriate use of iron in HF These uncertainties include longer-term sustainability of beneficial effects, safety, and potential impact on outcomes.
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