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European Journal of Heart Failure 2008 10(1):89-95; doi:10.1016/j.ejheart.2007.10.012
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© 2008 European Society of Cardiology

A randomised trial of a pre-synaptic stimulator of DA2-dopaminergic and {alpha}2-adrenergic receptors on morbidity and mortality in patients with heart failure

Christian Torp-Pedersena,*, Lars Køberb, Jan E. Carlsenc, Dilek Akkand, Niels E. Bruund, Dimitri Dacoroniase, Kenneth Dicksteinf, Torben Haghfeltg, Hans Öhlinh and John JV McMurrayi

a Dept. Cardiology, Bispebjerg University Hospital, Bispebjerg Bakke 2400 Copenhagen NV, Denmark
b Department of Cardiology, The National Hospital Copenhagen, Denmark
c Cyncron A/S Copenhagen, Denmark
d Department of Cardiology, Gentofte University Hospital Copenhagen, Denmark
e Corporate Medical Department, Chiesi Farmaceutici S.p.A. Parma Italy
f Cardiology Division, University of Bergen, Stavanger University Hospital Norway
g Department of Cardiology, Odense University Hospital Odense, Denmark
h Department of Cardiology, University Hospital Lund, Sweden
i Department of Cardiology, Western Infirmary Glasgow, Scotland, UK

* Corresponding author. Tel.: +45 35316161; fax: +45 39760107. E-mail address: ctp{at}heart.dk (C. Torp-Pedersen).


  Abstract

Background: By pre-synaptic stimulation of DA2-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.

Key Words: Nolomirole • Heart failure • Survival • Controlled clinical trial

Received August 26, 2007; Accepted October 18, 2007


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