High Heart Rate
Conditions
Keywords
Heart rate, Dialysis, ESRD, ivabradine
Brief summary
A significant association between resting heart rate (HR) and both all-cause mortality and cardiovascular mortality has been demonstrated in numerous epidemiologic studies for both the general population and for patients with cardiovascular disease. Cardiac disease is the leading cause of death among hemodialysis (HD) patients a recent study reported that the 48-hr mean HR is an independent predictor of cardiovascular events in normotensive hemodialysis patients. Ivabradine, a pure HR lowering agent,acting on If current inhibition has proven beneficial antianginal effects and mortality reduction linked to HR reduction in ischemic patients. Aim: To evaluate the safety and efficacy of ivabradine in normotensive hemodialysed patients with increased pre-dialysis HR (\> 80 bpm)
Interventions
DRUGIvabradine
Ivabradine 5 mg BID titrated to 7.5 mg if tolerated
DRUGPlacebo
Matched placebo
Sponsors
University of Campania Luigi Vanvitelli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Dialysis patients * Sinus rhythm * Pre-dialytic Heart rate \> 80 bpm
Exclusion criteria
* Atrial fibrillation/atrial flutter * Heart failure * Valvular disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Heart rate | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients that experienced hypotension | 1 year |
Countries
Italy
Outcome results
None listed