PMID- 15500398
OWN - NLM
STAT- MEDLINE
DCOM- 20051102
LR  - 20220228
IS  - 1744-7658 (Electronic)
IS  - 1354-3784 (Linking)
VI  - 13
IP  - 11
DP  - 2004 Nov
TI  - Rationale, design and organisation of an efficacy and safety study of oxypurinol 
      added to standard therapy in patients with NYHA class III - IV congestive heart 
      failure.
PG  - 1509-16
AB  - Oxypurinol, the active metabolite of allopurinol and a potent xanthine oxidase 
      inhibitor (XOI), is under evaluation as a novel agent for the treatment of 
      congestive heart failure (HF). Several lines of evidence provide the rationale 
      for the hypothesis that XOIs will improve clinical outcomes in patients with HF. 
      First, XOIs have unique positive inotropic effects, improving myocardial 
      contraction and performance while simultaneously improving myocardial energy 
      metabolism. Second, XOIs ameliorate endothelial dysfunction in humans with HF. 
      Finally, XO activity is upregulated in the heart and vasculature of subjects with 
      HF, which may in turn contribute to oxidative stress and/or increased uric acid 
      levels. Together these findings form the rationale for the Controlled Efficacy 
      and Safety Study of Oxypurinol Added to Standard Therapy in Patients with New 
      York Heart Association (NYHA) class III - IV Congestive Heart Failure (OPT-CHF) 
      trial (Food and Drug Administration IND 65,125), a Phase II - III prospective, 
      randomised, double-blind, placebo-controlled trial, which will include patients 
      with stable symptomatic HF in NYHA class III - IV congestive HF who are deemed 
      clinically stable on a standard and appropriately maximised heart failure therapy 
      regimen. The efficacy end point for OPT-CHF is a composite that incorporates 
      measures of patient outcome and well-being.
FAU - Freudenberger, Ronald S
AU  - Freudenberger RS
AD  - Univerfsity of Medicine and Dentistry of New Jersey, USA.
FAU - Schwarz, Richard P Jr
AU  - Schwarz RP Jr
FAU - Brown, Joanne
AU  - Brown J
FAU - Moore, Alan
AU  - Moore A
FAU - Mann, Douglas
AU  - Mann D
FAU - Givertz, Michael M
AU  - Givertz MM
FAU - Colucci, Wilson S
AU  - Colucci WS
FAU - Hare, Joshua M
AU  - Hare JM
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase II
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - England
TA  - Expert Opin Investig Drugs
JT  - Expert opinion on investigational drugs
JID - 9434197
RN  - EC 1.17.3.2 (Xanthine Oxidase)
RN  - G97OZE5068 (Oxypurinol)
SB  - IM
MH  - Double-Blind Method
MH  - Heart Failure/*classification/*drug therapy
MH  - Humans
MH  - Oxypurinol/administration & dosage/*adverse effects/pharmacology/*therapeutic use
MH  - Research Design
MH  - Xanthine Oxidase/antagonists & inhibitors/metabolism
EDAT- 2004/10/27 09:00
MHDA- 2005/11/03 09:00
CRDT- 2004/10/27 09:00
PHST- 2004/10/27 09:00 [pubmed]
PHST- 2005/11/03 09:00 [medline]
PHST- 2004/10/27 09:00 [entrez]
AID - EID131111 [pii]
AID - 10.1517/13543784.13.11.1509 [doi]
PST - ppublish
SO  - Expert Opin Investig Drugs. 2004 Nov;13(11):1509-16. doi: 
      10.1517/13543784.13.11.1509.