A randomised trial of a pre-synaptic stimulator of DA2-dopaminergic and alpha2-adrenergic receptors on morbidity and mortality in patients with heart failure

TY - JOUR

T1 - A randomised trial of a pre-synaptic stimulator of DA2-dopaminergic and alpha2-adrenergic receptors on morbidity and mortality in patients with heart failure

AU - Torp-Pedersen, Christian

AU - Køber, Lars

AU - Carlsen, Jan E

AU - Akkan, Dilek

AU - Bruun, Niels E

AU - Dacoronias, Dimitri

AU - Dickstein, Kenneth

AU - Haghfelt, Torben

AU - Ohlin, Hans

AU - McMurray, John J V

N1 - Keywords: Aged; Double-Blind Method; Esters; Female; Heart Failure; Hospitalization; Humans; Kaplan-Meiers Estimate; Male; Prospective Studies; Receptors, Adrenergic, alpha-2; Receptors, Dopamine D2; Tetrahydronaphthalenes; Time Factors; Treatment Outcome; Ventricular Dysfunction, Left

PY - 2008

Y1 - 2008

N2 - 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. (c) 2007 European Society of Cardiology. Published by Elsevier B.V. All rights reserved Udgivelsesdato: 2008/1

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. (c) 2007 European Society of Cardiology. Published by Elsevier B.V. All rights reserved Udgivelsesdato: 2008/1

U2 - 10.1016/j.ejheart.2007.10.012

DO - 10.1016/j.ejheart.2007.10.012

M3 - Journal article

C2 - 18164245

SN - 1388-9842

VL - 10

SP - 89

EP - 95

JO - European Journal of Heart Failure

JF - European Journal of Heart Failure

IS - 1

ER -