PMID- 25176939
OWN - NLM
STAT- MEDLINE
DCOM- 20151215
LR  - 20220330
IS  - 1522-9645 (Electronic)
IS  - 0195-668X (Print)
IS  - 0195-668X (Linking)
VI  - 36
IP  - 11
DP  - 2015 Mar 14
TI  - Beneficial effects of long-term intravenous iron therapy with ferric 
      carboxymaltose in patients with symptomatic heart failure and iron deficiencydagger.
PG  - 657-68
LID - 10.1093/eurheartj/ehu385 [doi]
AB  - 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).
CI  - (c) The Author 2014. Published by Oxford University Press on behalf of the European 
      Society of Cardiology.
FAU - Ponikowski, Piotr
AU  - Ponikowski P
AD  - 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.
FAU - van Veldhuisen, Dirk J
AU  - van Veldhuisen DJ
AD  - Department of Cardiology, University Medical Center Groningen, University of 
      Groningen, Groningen, The Netherlands.
FAU - Comin-Colet, Josep
AU  - Comin-Colet J
AD  - Heart Diseases Biomedical Research Group, IMIM (Hospital del Mar Medical Research 
      Institute), Barcelona, Spain.
FAU - Ertl, Georg
AU  - Ertl G
AD  - Department of Internal Medicine I, University Hospital Wurzburg, Wurzburg, 
      Germany Comprehensive Heart Failure Center, University of Wurzburg, Wurzburg, 
      Germany.
FAU - Komajda, Michel
AU  - Komajda M
AD  - CHU Pitie-Salpetriere, Institut de Cardiologie, Paris, France.
FAU - Mareev, Viacheslav
AU  - Mareev V
AD  - Lomonosov Moscow State University, Moscow, Russia.
FAU - McDonagh, Theresa
AU  - McDonagh T
AD  - Department of Cardiology, King's College Hospital, Denmark Hill, London SE5 9RS, 
      UK.
FAU - Parkhomenko, Alexander
AU  - Parkhomenko A
AD  - Ukranian Strazhesko Institute of Cardiology, 5, Narodnoko Opolchenia St, Kiev 
      03151, Ukraine.
FAU - Tavazzi, Luigi
AU  - Tavazzi L
AD  - Maria Cecilia Hospital, GVM Care&Research-E.S. Health Science Foundation, 
      Cotignola, Italy.
FAU - Levesque, Victoria
AU  - Levesque V
AD  - Vifor Pharma, Glattbrugg, Switzerland.
FAU - Mori, Claudio
AU  - Mori C
AD  - Vifor Pharma, Glattbrugg, Switzerland.
FAU - Roubert, Bernard
AU  - Roubert B
AD  - Vifor Pharma, Glattbrugg, Switzerland.
FAU - Filippatos, Gerasimos
AU  - Filippatos G
AD  - Athens University Hospital Attikon, Athens, Greece.
FAU - Ruschitzka, Frank
AU  - Ruschitzka F
AD  - Department of Cardiology, University Hospital Zurich, Switzerland.
FAU - Anker, Stefan D
AU  - Anker SD
AD  - Department of Innovative Clinical Trials, University Medical Centre Gottingen, 
      Gottingen, Germany.
CN  - CONFIRM-HF Investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT01453608
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140831
PL  - England
TA  - Eur Heart J
JT  - European heart journal
JID - 8006263
RN  - 0 (Cardiotonic Agents)
RN  - 0 (Ferric Compounds)
RN  - 6897GXD6OE (ferric carboxymaltose)
RN  - 69-79-4 (Maltose)
SB  - IM
CIN - Nat Rev Cardiol. 2014 Nov;11(11):622. PMID: 25223446
CIN - Eur Heart J. 2015 Mar 14;36(11):645-7. PMID: 25336211
MH  - Aged
MH  - Cardiotonic Agents/*administration & dosage
MH  - Double-Blind Method
MH  - Female
MH  - Ferric Compounds/*administration & dosage
MH  - Heart Failure/*drug therapy
MH  - Hospitalization/statistics & numerical data
MH  - Humans
MH  - Injections, Intravenous
MH  - *Iron Deficiencies
MH  - Long-Term Care
MH  - Male
MH  - Maltose/administration & dosage/*analogs & derivatives
MH  - Quality of Life
MH  - Treatment Outcome
PMC - PMC4359359
OTO - NOTNLM
OT  - Ferric carboxymaltose
OT  - Heart failure
OT  - Iron deficiency
EDAT- 2014/09/02 06:00
MHDA- 2015/12/17 06:00
PMCR- 2014/08/31
CRDT- 2014/09/02 06:00
PHST- 2014/09/02 06:00 [entrez]
PHST- 2014/09/02 06:00 [pubmed]
PHST- 2015/12/17 06:00 [medline]
PHST- 2014/08/31 00:00 [pmc-release]
AID - ehu385 [pii]
AID - 10.1093/eurheartj/ehu385 [doi]
PST - ppublish
SO  - Eur Heart J. 2015 Mar 14;36(11):657-68. doi: 10.1093/eurheartj/ehu385. Epub 2014 
      Aug 31.