Abstract
While beta-blockers are considered contraindicated in pulmonary arterial hypertension (PAH), the prognostic significance of sympathetic nervous system over-activity suggests a potential benefit of beta-blocker therapy. The aim of this randomised, placebo-controlled, crossover, single centre study was to determine the effects of bisoprolol on right ventricular ejection fraction (RVEF) in idiopathic PAH (iPAH) patients. Additional efficacy and safety parameters were explored.
Patients with optimally treated, stable iPAH (New York Heart Association functional class II/III) were randomised to placebo or bisoprolol. Imaging and functional measurements were performed at baseline, crossover and end of study.
18 iPAH patients were included, because inclusion faltered before enrolment of the targeted 25 patients. 17 patients completed 6 months of bisoprolol, 15 tolerated bisoprolol, one patient required intravenous diuretics. Bisoprolol was associated with a lower heart rate (17 beats per minute, p=0.0001) but RVEF remained unchanged. A drop in cardiac index (0.5 L·min−1·m−2, p=0.015) was observed, along with a trend towards a decreased 6-min walking distance (6MWD).
Although careful up-titration of bisoprolol was tolerated by most patients and resulted in a decreased heart rate, no benefit of bisoprolol in iPAH was demonstrated. Decreases in cardiac index and 6MWD suggest a deteriorated cardiac function. The results do not favour the use of bisoprolol in iPAH patients.
Abstract
A bisoprolol dose that significantly reduced heart rate was not associated with a significant change in RVEF in PAH http://ow.ly/j5D0300OgGz
Footnotes
Editorial comment in Eur Respir J 2016; 48: 617–618.
This article has supplementary material available from erj.ersjournals.com
Clinical trial: The study was registered at clinicaltrials.gov with identifier number NCT01246037 and clinicaltrialsregister.eu (EudraCT) with identifier number 2010-020424-21.
Support statement: This research was financially supported by a ZonMW grant (number: 95110079). Funding information for this article has been deposited with the Open Funder Registry.
Conflict of interest: Disclosures can be found alongside this article at erj.ersjournals.com
- Received September 21, 2015.
- Accepted May 21, 2016.
- Copyright ©ERS 2016