PMID- 28834668
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20191120
IS  - 2055-5822 (Electronic)
IS  - 2055-5822 (Linking)
VI  - 1
IP  - 1
DP  - 2014 Sep
TI  - Rationale and design of the CONFIRM-HF study: a double-blind, randomized, 
      placebo-controlled study to assess the effects of intravenous ferric 
      carboxymaltose on functional capacity in patients with chronic heart failure and 
      iron deficiency.
PG  - 52-58
LID - 10.1002/ehf2.12006 [doi]
AB  - BACKGROUND: Iron deficiency (ID) is a common co-morbidity associated with chronic 
      heart failure (CHF), which has unfavourable clinical and prognostic consequences. 
      In Ferinject Assessment in Patients with IRon Deficiency and Chronic Heart 
      Failure (FAIR-HF), the treatment with i.v. ferric carboxymaltose (FCM) improved 
      symptoms and quality of life over a 24 week period. Ferric CarboxymaltOse 
      evaluatioN on perFormance in patients with IRon deficiency in coMbination with 
      chronic Heart Failure (CONFIRM-HF) was designed to test a simplifieddosage scheme 
      of FCM during a longer follow-up period. METHODS: CONFIRM-HF, a double-blind, 
      multi-centre, prospective, randomized, two-arm study, enrolled ambulatory 
      patients with symptomatic CHF [New York Heart Association (NYHA) class II/III] 
      with left ventricular ejection fraction </=45%, BNP >100 pg/mL, or NT-proBNP 
      >400 pg/mL, presence of ID [defined as ferritin <100 ng/mL, or ferritin 
      100-300 ng/mL if transferrin saturation (TSAT) <20%], and haemoglobin (Hb) 
      <15 g/dL. Patients were randomized 1:1 to treatment with FCM or placebo for 
      52 weeks. Primary endpoint is change in 6-minute walk test (6MWT) distance from 
      baseline to Week 24. Secondary endpoints are: change in 6MWT from baseline to 
      Weeks 6, 12, 36, and 52; Patient Global Assessment score at Weeks 6, 12, 24, 36, 
      and 52; and change from baseline to Weeks 6, 12, 24, 36, and 52 in NYHA class, 
      fatigue score, and quality of life. Safety endpoints include overall safety over 
      the treatment period of 52 weeks. Study medication was administered in single 
      doses as undiluted bolus injection of up to 1000 mg of iron or normal saline at 
      Day 0 and Week 6 up to iron repletion. Further doses of study medication could be 
      administered at Weeks 12, 24, and 36 if a patient still had ID. RESULTS: Overall, 
      304 patients were recruited in 41 centres in nine countries. CONCLUSION: This 
      study will provide further information on the efficacy and safety of iron therapy 
      with i.v. FCM in CHF patients with ID over a 1 year period using a simplified 
      dosing scheme.
CI  - (c) 2014 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on 
      behalf of the European Society of Cardiology.
FAU - Ponikowski, Piotr
AU  - Ponikowski P
AD  - Department of Cardiology, Military Hospital, Wroclaw, Poland.
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  - Hospital del Mar (IMAS) & Universitat Autonoma de Barcelona Barcelona, Barcelona, 
      Spain.
FAU - Ertl, Georg
AU  - Ertl G
AD  - Department of Cardiology, University Wurzburg, Wurzburg, Germany.
FAU - Komajda, Michel
AU  - Komajda M
AD  - Department of Cardiology, University Pierre et Marie Curie, Paris VI and Pitie 
      Salpetriere Hospital, AP-HP, Paris, France.
FAU - Mareev, Viacheslav
AU  - Mareev V
AD  - A. L. Myasnikov Cardiology Institute, Moscow, Russia.
FAU - McDonagh, Theresa A
AU  - McDonagh TA
AD  - King's College Hospital, London, UK.
FAU - Parkhomenko, Alexander
AU  - Parkhomenko A
AD  - Center 'M.D. Strazhesko Institute of Cardiology', National Medical Academy of 
      Science, Kiev, 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 Ltd, Glattbrugg, Switzerland.
FAU - Mori, Claudio
AU  - Mori C
AD  - Vifor Pharma Ltd, Glattbrugg, Switzerland.
FAU - Roubert, Bernard
AU  - Roubert B
AD  - Vifor Pharma Ltd, Glattbrugg, Switzerland.
FAU - Filippatos, Gerasimos
AU  - Filippatos G
AD  - Department of Cardiology, University Athens, Athens, Greece.
FAU - Ruschitzka, Frank
AU  - Ruschitzka F
AD  - University Hospital Zurich, Zurich, Switzerland.
FAU - Anker, Stefan D
AU  - Anker SD
AD  - Department of Innovative Clinical Trials, University Medical Centre Gottingen, 
      Gottingen, Germany.
LA  - eng
PT  - Journal Article
PL  - England
TA  - ESC Heart Fail
JT  - ESC heart failure
JID - 101669191
OTO - NOTNLM
OT  - Chronic heart failure
OT  - Ferric carboxymaltose
OT  - Functional capacity
OT  - Iron deficiency
OT  - Treatment
EDAT- 2014/09/01 00:00
MHDA- 2014/09/01 00:01
CRDT- 2017/08/24 06:00
PHST- 2014/07/22 00:00 [received]
PHST- 2014/07/27 00:00 [accepted]
PHST- 2017/08/24 06:00 [entrez]
PHST- 2014/09/01 00:00 [pubmed]
PHST- 2014/09/01 00:01 [medline]
AID - 10.1002/ehf2.12006 [doi]
PST - ppublish
SO  - ESC Heart Fail. 2014 Sep;1(1):52-58. doi: 10.1002/ehf2.12006.