Ivabradine in Hemodialysed Patients With Increased Heart Rate

University of Campania "Luigi Vanvitelli"

Status and phase: Unknown; Phase 4

Conditions: High Heart Rate

Treatments: Drug: Placebo; Drug: Ivabradine

Study type: Interventional

Funder types: Other

Identifiers

NCT01364077

IV-DIAL.01

IV-DIAL.01-A (Other Identifier)

Details and patient eligibility

About

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)

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Dialysis patients
• Sinus rhythm
• Pre-dialytic Heart rate > 80 bpm

Exclusion criteria

• Atrial fibrillation/atrial flutter
• Heart failure
• Valvular disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Ivabradine

Active Comparator group

Treatment:

Drug: Ivabradine

Control

Placebo Comparator group

Treatment:

Drug: Placebo