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

Phase 4

Completed

• Conditions: Heart Failure
• Interventions: Drug: Ivabradine

• Registration Number: NCT01373619
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-01
• Study Start: 2010-01
• Primary Completion: 2011-01
• Study First Submitted: 2011-05-25
• Study First Submitted QC: 2011-06-14
• Study First Posted: 2011-06-15
• Study Completion: 2012-01
• Last Update Submitted: 2012-01-18
• Last Update Posted: 2012-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IVABRADINE, HEART FAILURE WITH NORMAL EF	Ivabradine	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

Primary Outcome Measures

Name	Time	Method
Echocardiofic changes of diastolic left ventricular function	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

Name	Time	Method
changes in 6-minutes walking test	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.
changes in NYHA class	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.

Trial Locations

Locations (1)

Chair of Cardiology Second Univesity of Naples; 🇮🇹 Naples, Italy