Abstract
Iron deficiency is common in patients with heart failure (HF) and is associated with reduced exercise capacity and poor outcomes. Whether correction of iron deficiency with (intravenous) ferric carboxymaltose (FCM) affects peak oxygen consumption [peak VO2], an objective measure of exercise intolerance in HF, has not been examined. We studied patients with systolic HF (left ventricular ejection fraction ≤45%) and mild to moderate symptoms despite optimal HF medication. Patients were randomized 1:1 to treatment with FCM for 24 weeks or standard of care. The primary end point was the change in peak VO2 from baseline to 24 weeks. Secondary end points included the effect on hematinic and cardiac biomarkers, quality of life, and safety. For the primary analysis, patients who died had a value of 0 imputed for 24-week peak VO2. Additional sensitivity analyses were performed to determine the impact of imputation of missing peak VO2 data. A total of 172 patients with HF were studied and received FCM (n=86) or standard of care (control group, n=86). At baseline, the groups were well matched; mean age was 64 years, 75% were male, mean left ventricular ejection fraction was 32%, and peak VO2 was 13.5 mL/min/kg. FCM significantly increased serum ferritin and transferrin saturation. At 24 weeks, peak VO2 had decreased in the control group (least square means -1.19±0.389 mL/min/kg) but was maintained on FCM (-0.16±0.387 mL/min/kg; P=0.020 between groups). In a sensitivity analysis, in which missing data were not imputed, peak VO2 at 24 weeks decreased by -0.63±0.375 mL/min/kg in the control group and by -0.16±0.373 mL/min/kg in the FCM group; P=0.23 between groups). Patients' global assessment and functional class as assessed by the New York Heart Association improved on FCM versus standard of care. Treatment with intravenous FCM in patients with HF and iron deficiency improves iron stores. Although a favorable effect on peak VO2 was observed on FCM, compared with standard of care in the primary analysis, this effect was highly sensitive to the imputation strategy for peak VO2 among patients who died. Whether FCM is associated with an improved outcome in these high-risk patients needs further study. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01394562.
Highlights
Iron deficiency is common in patients with heart failure (HF) and is associated with reduced exercise capacity and poor outcomes
Iron deficiency is increasingly recognized as a serious comorbidity in patients with heart failure and is associated with increased morbidity and mortality
Of the 172 patients, 161 patients could be examined for the primary end point: effect on peak VO2 during cardiopulmonary exercise testing (CPET) after 24 weeks (Figure 1)
Summary
We studied patients with systolic HF (left ventricular ejection fraction ≤45%) and mild to moderate symptoms despite optimal HF medication. Patients were eligible for the EFFECT-HF study if they were ≥18 years of age, had clinically stable mild to moderate chronic HF (New York Heart Association [NYHA] functional class II‒III), and were on optimal background therapy for HF for ≥4 weeks and with no dose changes in the last 2 weeks. Their left ventricular ejection fraction had to be ≤45% and had to be performed in ≤3 months of screening and >3 months after stable β-blocker therapy or device implantation, in particular cardiac resynchronization therapy. Ethical approval was obtained from the Medical Ethics Committee of each participating center, and all subjects gave their written informed consent before enrollment
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