Early Use of Ivabradine in Heart Failure

NCT ID: NCT03701880

Last Updated: 2018-10-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-16
• Study Completion Date: 2019-12-23

Brief Summary

The aim of the work is to Evaluate the efficacy, quality of life and safety of early addition of ivabradine to B-blocker in reduced EF heart failure patients after acute decompensation compared to the standard treatment.

Detailed Description

this study is a Prospective randomized open label study will be conducted on Egyptian patient with heart failure with reduced ejection fraction(rEF HF). Each of the eligible patients will be randomized to one of these groups, early administration of Ivabradine and B-blocker group or control group which follows American Heart Association treatment guidelines of rEF HF.

The objectives include the following:

1. Physical examination (heart rate, blood pressure, dyspnea and orthopnea symptoms)

2. NYHA class

3. Pro-NT-BNP serum level, ST2 serum level

4. Echocardiography (left ventricular ejection fraction)

5. Score of Minnesota Living with Heart Failure Questionnaire these objectives will be measured baseline, 2 weeks and after 3 months

Conditions

Heart Failure With Reduced Ejection Fraction; Decompensated Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ivabradine group

an initial dose of 5 mg/12 hours of Ivabradine will be added to beta-blockers (bisoprolol 2.5 mg/day) and ivabradine will be increased until a dose of 7.5 mg/12 hours according to HR. The heart rate target will be at least \<70 bpm and not lower than 60 bpm. If HR decreases below 60 bpm, ivabradine and/or beta-blockers doses will be decreased to the previous dose. After discharge, beta-blockers up-titration will be continued during follow-up visit.

Group Type: EXPERIMENTAL

Ivabradine

Intervention Type: DRUG

Ivabradine is pacemaker current I(f) inhibitor thereby slowing heart rates without exhibiting negative inotropic effect on the myocardium or altering ventricular action potential

Bisoprolol

Intervention Type: DRUG

Bisoprolol is beta-blocker

Control group

beta-blocker (bisoprolol 2.5 mg/day) and it will be doubled every 2 weeks during the admission according to the stability of HR, blood pressure and tolerability of patients. Ivabradine will be only added after reaching bisoprolol optimal dose (10mg) or maximum tolerated dose and the HR is still above 70 bpm. If HR decreases below 60 bpm, ivabradine dose will be decreased.

Group Type: ACTIVE_COMPARATOR

Ivabradine

Intervention Type: DRUG

Ivabradine is pacemaker current I(f) inhibitor thereby slowing heart rates without exhibiting negative inotropic effect on the myocardium or altering ventricular action potential

Bisoprolol

Intervention Type: DRUG

Bisoprolol is beta-blocker

Interventions

Ivabradine

Ivabradine is pacemaker current I(f) inhibitor thereby slowing heart rates without exhibiting negative inotropic effect on the myocardium or altering ventricular action potential

Intervention Type: DRUG

Bisoprolol

Bisoprolol is beta-blocker

Intervention Type: DRUG

Other Intervention Names

Procoralan; concor

Eligibility Criteria

Inclusion Criteria

1. Patient with acute heart failure either newly diagnosed or decompensated heart failure after stabilization

2. Patients > 18 years old

3. Left ventricular ejection fraction less than 40 % of presumed irreversible etiology

4. Clinically stable 24-48 hours after admission

5. Sinus rhythm with heart rate above 70 bpm

6. No previous treatment with ivabradine

Exclusion Criteria

1. Patients less than 18 years.

2. Arterial fibrillation before inclusion.

3. Ventricular dysfunction due to acute event (Myocarditis, AMI). 4- cardiogenic shock

5. Patients are taking drug interact with ivabradine. 6- carrier or candidate for pacemaker, heart transportation, cardiac surgery or other cardiovascular procedure

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sadat City University

OTHER

Sponsor Role: collaborator

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Nouran Ahmed Aly

Teaching Assistant of Clinical Pharmacy department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

El Demerdash Hospital

Cairo, , Egypt

Countries

Egypt

Other Identifiers

ClinicalPH110

Identifier Type: -

Identifier Source: org_study_id