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Clinical Trials/NCT01373619
NCT01373619
Completed
Phase 4

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

University of Campania "Luigi Vanvitelli"1 site in 1 country150 target enrollmentJanuary 2010
ConditionsHeart Failure
InterventionsIvabradine

Overview

Phase
Phase 4
Intervention
Ivabradine
Conditions
Heart Failure
Sponsor
University of Campania "Luigi Vanvitelli"
Enrollment
150
Locations
1
Primary Endpoint
Echocardiofic changes of diastolic left ventricular function
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
January 2012
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility 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

Arms & Interventions

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

Intervention: Ivabradine

Outcomes

Primary Outcomes

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 Outcomes

  • changes in 6-minutes walking test(baseline, 1,3,6,9,12 months)
  • changes in NYHA class(baseline, 1,3,6,9,12 months)

Study Sites (1)

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