Healthy Clinical Trial
Official title:
Effect of Pharmacological Heart Rate Reduction on Visco-elastic Properties of the Arterial Wall (BRADYVASC)
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.
n/a
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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