NCT01373619

Brief Summary

Heart failure with normal ejection fraction is often under diagnosed and certainly under treated in hemodialyzed patients. Because of the benefit of reducing heart rate, ivabradine, a pure heart-rate lowering agent without effects on blood pressure, is of potential therapeutic utility.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for phase_4 heart-failure

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

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
21 days until next milestone

First Posted

Study publicly available on registry

June 15, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 19, 2012

Status Verified

January 1, 2010

Enrollment Period

1 year

First QC Date

May 25, 2011

Last Update Submit

January 18, 2012

Conditions

Heart Failure

Keywords

Heart failure with normal ejection fractionhemodialysis patientsivabradineEchocardiographyNYHA class6-minutes walking test

Outcome Measures

Primary Outcomes (1)

  • Echocardiofic changes of diastolic left ventricular function

    Measures of diastolic left ventricular function (E and A velocity and deceleration time of mitral inflow and Doppler-Tissue-Imaging E velocity and their ratio) were assessed at baseline and at each scheduled time.

    baseline, 1, 3, 6, 9, 12 months

Secondary Outcomes (2)

  • changes in NYHA class

    baseline, 1,3,6,9,12 months

  • changes in 6-minutes walking test

    baseline, 1,3,6,9,12 months

Study Arms (1)

IVABRADINE, HEART FAILURE WITH NORMAL EF

EXPERIMENTAL

Patient on hemodialysis with Heart failure with normal ejection fraction treated with ivabradine titrated to 7.5 mg BID to assess changes in echocardiography diastolic function and NYHA class and 6-minutes walking test

Drug: Ivabradine

Interventions

IvabradineDRUG

ivabradine titrated to 7.5 mg BID

Also known as: Procoralan, Corlentor
IVABRADINE, HEART FAILURE WITH NORMAL EF

Eligibility Criteria

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

You may qualify if:

  • hemodialyzed patients
  • signs and symptoms of heart failure with normal ejection fraction
  • sinus rhythm

You may not qualify if:

  • atrial fibrillation/atrial flutter
  • valvular heart disease
  • unstable angina
  • hospitalization for heart failure prior 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chair of Cardiology Second Univesity of Naples

Naples, 80100, Italy

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Ivabradine

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Gennaro Cice, MD

    University of Campania Luigi Vanvitelli

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 25, 2011

First Posted

June 15, 2011

Study Start

January 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2012

Last Updated

January 19, 2012

Record last verified: 2010-01

Locations

IT(1)