Heart Failure With Normal Ejection Fraction (HFNEF) in Hemodialysed Patients: Beneficial Effect of Ivabradine

January 18, 2012 updated by: University of Campania "Luigi Vanvitelli"
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80100
        • Chair of Cardiology Second Univesity of Naples

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IVABRADINE, HEART FAILURE WITH NORMAL EF
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
ivabradine titrated to 7.5 mg BID
Other Names:
  • Procoralan
  • Corlentor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Echocardiofic changes of diastolic left ventricular function
Time Frame: baseline, 1, 3, 6, 9, 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in NYHA class
Time Frame: baseline, 1,3,6,9,12 months
Measures of New York Heart Association functional class stratified I to IV at baseline and at each scheduled time.
baseline, 1,3,6,9,12 months
changes in 6-minutes walking test
Time Frame: baseline, 1,3,6,9,12 months
American Thoracic Society At baseline and at each scheduled time a 6-minutes walking test were performed according ATS Statement. The following measures were analysed at starting and ending test: heart rate; blood pressure, dyspnea according the Borg scale, fatigue according the Borg scale, Spo2%;distance walked, symptoms.
baseline, 1,3,6,9,12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campania "Luigi Vanvitelli"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

May 25, 2011

First Submitted That Met QC Criteria

June 14, 2011

First Posted (Estimate)

June 15, 2011

Study Record Updates

Last Update Posted (Estimate)

January 19, 2012

Last Update Submitted That Met QC Criteria

January 18, 2012

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HFNEF-IVA-DIAL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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