The main question of this study is: 'Is selective beta-blocker treatment safe and effective
in reducing sympathetic overdrive, thereby improving RV function and remodeling in patients
with iPAH?'.
In addition to the determination of RVEF, the investigators will explore how beta-blocker
therapy affects sympathetic overdrive, remodeling of the RV, single beat elastance, exercise
capacity and mechanical efficiency.
30 iPAH patients will be randomized to either Bisoprolol- or placebo-treatment in a
double-blinded fashion. A cross-over trial design will be used to increase the power of the
study and to assess long-term effects of Bisoprolol-treatment and -withdrawal. The medication
will be given in an escalating dose regimen (as described in the 'farmacotherapeutisch
kompas', www.fk.cvz.nl) and treatment will be monitored along the guidelines of the American
Heart Association.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
VU University Medical Center
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development