Περίληψη:
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.
Συγγραφείς:
Ponikowski, Piotr
van Veldhuisen, Dirk J.
Comin-Colet, Josep and
Ertl, Georg
Komajda, Michel
Mareev, Viacheslav
McDonagh,
Theresa
Parkhomenko, Alexander
Tavazzi, Luigi
Levesque,
Victoria
Mori, Claudio
Roubert, Bernard
Filippatos,
Gerasimos
Ruschitzka, Frank
Anker, Stefan D.
CONFIRM-HF
Investigators
