NCT01364077

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)

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 2, 2011

Completed
Last Updated

June 21, 2012

Status Verified

June 1, 2012

Enrollment Period

1 year

First QC Date

May 25, 2011

Last Update Submit

June 20, 2012

Conditions

High Heart Rate

Keywords

Heart rateDialysisESRDivabradine

Outcome Measures

Primary Outcomes (1)

  • Heart rate

    1 year

Secondary Outcomes (1)

  • Number of patients that experienced hypotension

    1 year

Study Arms (2)

Ivabradine

ACTIVE COMPARATOR
Drug: Ivabradine

Control

PLACEBO COMPARATOR
Drug: Placebo

Interventions

IvabradineDRUG

Ivabradine 5 mg BID titrated to 7.5 mg if tolerated

Ivabradine
PlaceboDRUG

Matched placebo

Control

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chair of Cardiology

Naples, 80100, Italy

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Ivabradine

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Gennaro Cice, MD

    Second Univesity of Naples

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 25, 2011

First Posted

June 2, 2011

Study Start

January 1, 2010

Primary Completion

January 1, 2011

Last Updated

June 21, 2012

Record last verified: 2012-06

Locations

IT(1)