Effect of Pharmacological Heart Rate Reduction on Visco-elastic Properties of the Arterial Wall (BRADYVASC)
Status:
Unknown status
Trial end date:
2017-09-01
Target enrollment:
Participant gender:
Summary
The conduit arteries exhibit a viscoelastic behavior. Visco-elasticity is partially regulated
by endothelium and contributes to the optimization of the heart-vessel coupling. Aging or
high resting heart rate (HR) could alter visco-elastic properties leading to increase
stiffness of the conduit arteries, an independent cardiovascular risk factor, and degradation
of heart-vessel coupling. Lowering HR with ivabradine could reduce these effects.
The objective of this study is to assess the effect of HR reduction by repeated
administration of ivabradine on visco-elastic properties, vascular geometry and function of
common carotid artery, and on cardiovascular hemodynamic in healthy subject. The influence of
aging on ivabradine effects are studied too.
30 healthy volunteers aged between 25 and 65 years old, with a HR ≥ 70 bpm, will receive
ivabradine or placebo during 8 days in a single center, randomized, cross-group, double
blinded, placebo-controlled study. Each period of treatment will be separate by 12 to 16 days
of wash-out. Each subject will participate in an exploration visit, including evaluation of
visco-elastic properties, vascular geometry and function of common carotid artery, and
cardiovascular hemodynamic, before and after ivabradine or placebo taking.
Phase:
Phase 3
Details
Lead Sponsor:
University Hospital, Rouen
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France