A randomised trial of a pre-synaptic stimulator of DA(2)-dopaminergic and alpha(2)-adrenergic receptors on morbidity and mortality in patients with heart failure

Research output: Contribution to journalArticle

Abstract

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.

Details

Authors
  • Christian Torp-Pedersen
  • Lars Kober
  • Jan E. Carlsen
  • Dilek Akkan
  • Niels E. Bruun
  • Dimitri Dacoronias
  • Kenneth Dickstein
  • Torben Haghfelt
  • Hans Öhlin
  • John J. V. McMurray
Organisations
Research areas and keywords

Subject classification (UKÄ) – MANDATORY

  • Cardiac and Cardiovascular Systems

Keywords

  • heart failure, survival, nolomirole, controlled clinical trial
Original languageEnglish
Pages (from-to)89-95
JournalEuropean Journal of Heart Failure
Volume10
Issue number1
Publication statusPublished - 2008
Publication categoryResearch
Peer-reviewedYes