Heart Failure With Normal Ejection Fraction (HFNEF) in Hemodialysed Patients: Beneficial Effect of Ivabradine
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|ClinicalTrials.gov Identifier: NCT01373619|
Recruitment Status : Completed
First Posted : June 15, 2011
Last Update Posted : January 19, 2012
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Drug: Ivabradine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Heart Failure With Normal Ejection Fraction (HFNEF) in Hemodialysed Patients: Beneficial Effect of Ivabradine|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2012|
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
- 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.
- 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.
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
|Chair of Cardiology Second Univesity of Naples|
|Naples, Italy, 80100|
|Principal Investigator:||Gennaro Cice, MD||University of Campania "Luigi Vanvitelli"|