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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01373619
First Posted: June 15, 2011
Last Update Posted: January 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Campania "Luigi Vanvitelli"
  Purpose
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.

Condition Intervention Phase
Heart Failure Drug: Ivabradine Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Heart Failure With Normal Ejection Fraction (HFNEF) in Hemodialysed Patients: Beneficial Effect of Ivabradine

Resource links provided by NLM:


Further study details as provided by University of Campania "Luigi Vanvitelli":

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • 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.


Enrollment: 150
Study Start Date: January 2010
Study Completion Date: January 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01373619


Locations
Italy
Chair of Cardiology Second Univesity of Naples
Naples, Italy, 80100
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"
Investigators
Principal Investigator: Gennaro Cice, MD University of Campania "Luigi Vanvitelli"
  More Information

Responsible Party: Gennaro Cice, MD Second University of Naples, Second University of Naples
ClinicalTrials.gov Identifier: NCT01373619     History of Changes
Other Study ID Numbers: HFNEF-IVA-DIAL
First Submitted: May 25, 2011
First Posted: June 15, 2011
Last Update Posted: January 19, 2012
Last Verified: January 2010

Keywords provided by University of Campania "Luigi Vanvitelli":
Heart failure with normal ejection fraction
hemodialysis patients
ivabradine
Echocardiography
NYHA class
6-minutes walking test

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases