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

This study has been completed.
Sponsor:
Information provided by:
Second University of Naples
ClinicalTrials.gov Identifier:
NCT01373619
First received: May 25, 2011
Last updated: January 18, 2012
Last verified: January 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Second University of Naples:

Primary Outcome Measures:
  • Echocardiofic changes of diastolic left ventricular function [ Time Frame: baseline, 1, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01373619

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

No publications provided

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
Study First Received: May 25, 2011
Last Updated: January 18, 2012
Health Authority: Italy:Ministery of Health

Keywords provided by Second University of Naples:
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

ClinicalTrials.gov processed this record on June 18, 2013