PMID- 18164245
OWN - NLM
STAT- MEDLINE
DCOM- 20080603
LR  - 20121115
IS  - 1388-9842 (Print)
IS  - 1388-9842 (Linking)
VI  - 10
IP  - 1
DP  - 2008 Jan
TI  - A randomised trial of a pre-synaptic stimulator of DA2-dopaminergic and 
      alpha2-adrenergic receptors on morbidity and mortality in patients with heart 
      failure.
PG  - 89-95
LID - 10.1016/j.ejheart.2007.10.012 [doi]
AB  - BACKGROUND: By pre-synaptic stimulation of DA(2)-dopaminergic and 
      alpha(2)-adrenergic receptors, nolomirole inhibits norepinephrine secretion from 
      sympathetic nerve endings. We performed a clinical study with nolomirole in 
      patients with heart failure (HF). METHODS: The study was designed as a 
      multicentre, double blind, parallel group trial of 5 mg b.i.d. of nolomirole 
      (n=501) versus placebo (n=499) in patients with severe left ventricular systolic 
      dysfunction, recently in New York Heart Association (NYHA) class III/IV. The 
      primary endpoint was time to all cause death or hospitalisation for HF, whichever 
      came first. The study was event driven and required 420 primary events. The study 
      was completed as scheduled. RESULTS: Mean age of patients was 70 years, and 73% 
      were male. Heart rate and blood pressure were not different in the two treatment 
      groups. There were no changes in blood pressure. There were 233 primary events in 
      the nolomirole group versus 208 in the placebo group (p=0.1). There were 142/145 
      deaths and 369/374 all cause hospitalisations in the nolomirole/placebo groups. 
      There were no differences in walking distance, quality of life or NYHA class. 
      CONCLUSION: A dose of 5 mg b.i.d. of nolomirole was not beneficial (or harmful) 
      in patients with heart failure.
FAU - Torp-Pedersen, Christian
AU  - Torp-Pedersen C
AD  - Dept. Cardiology, Bispebjerg University Hospital, Bispebjerg Bakke, 2400 
      Copenhagen NV, Denmark. ctp@heart.dk
FAU - Kober, Lars
AU  - Kober L
FAU - Carlsen, Jan E
AU  - Carlsen JE
FAU - Akkan, Dilek
AU  - Akkan D
FAU - Bruun, Niels E
AU  - Bruun NE
FAU - Dacoronias, Dimitri
AU  - Dacoronias D
FAU - Dickstein, Kenneth
AU  - Dickstein K
FAU - Haghfelt, Torben
AU  - Haghfelt T
FAU - Ohlin, Hans
AU  - Ohlin H
FAU - McMurray, John J V
AU  - McMurray JJ
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20071227
PL  - England
TA  - Eur J Heart Fail
JT  - European journal of heart failure
JID - 100887595
RN  - 0 (ADRA2A protein, human)
RN  - 0 (Esters)
RN  - 0 (Receptors, Adrenergic, alpha-2)
RN  - 0 (Receptors, Dopamine D2)
RN  - 0 (Tetrahydronaphthalenes)
RN  - 6EMF80C55F (nolomirole)
SB  - IM
MH  - Aged
MH  - Double-Blind Method
MH  - Esters/*therapeutic use
MH  - Female
MH  - Heart Failure/*drug therapy/metabolism/mortality
MH  - Hospitalization
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Male
MH  - Prospective Studies
MH  - Receptors, Adrenergic, alpha-2/*drug effects
MH  - Receptors, Dopamine D2/*drug effects
MH  - Tetrahydronaphthalenes/*therapeutic use
MH  - Time Factors
MH  - Treatment Outcome
MH  - Ventricular Dysfunction, Left/*drug therapy/metabolism/mortality
EDAT- 2008/01/01 09:00
MHDA- 2008/06/05 09:00
CRDT- 2008/01/01 09:00
PHST- 2007/08/26 00:00 [received]
PHST- 2007/10/18 00:00 [accepted]
PHST- 2008/01/01 09:00 [pubmed]
PHST- 2008/06/05 09:00 [medline]
PHST- 2008/01/01 09:00 [entrez]
AID - S1388-9842(07)00468-0 [pii]
AID - 10.1016/j.ejheart.2007.10.012 [doi]
PST - ppublish
SO  - Eur J Heart Fail. 2008 Jan;10(1):89-95. doi: 10.1016/j.ejheart.2007.10.012. Epub 
      2007 Dec 27.