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

Study 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.

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

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Drug: Ivabradine


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IVABRADINE, HEART FAILURE WITH NORMAL EF<br>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<br>* ivabradine titrated to 7.5 mg BID<br>* Other names: Corlentor;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echocardiofic changes of diastolic left ventricular function | 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. | baseline, 1, 3, 6, 9, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in NYHA class | Measures of New York Heart Association functional class stratified I to IV at baseline and at each scheduled time. | baseline, 1,3,6,9,12 months | 
| changes in 6-minutes walking test | 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. | baseline, 1,3,6,9,12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NYHA class, Heart failure with normal ejection fraction, hemodialysis patients, ivabradine, Echocardiography, 6-minutes walking test