Heart Failure With Normal Ejection Fraction (HFNEF) in Hemodialysed Patients: Beneficial Effect of Ivabradine
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 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|
- 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.
- 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.
|Study Start Date:||January 2010|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
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
ivabradine titrated to 7.5 mg BID
Please refer to this study by its ClinicalTrials.gov identifier: NCT01373619
|Chair of Cardiology Second Univesity of Naples|
|Naples, Italy, 80100|
|Principal Investigator:||Gennaro Cice, MD||Second University of Naples|