Early Use of Ivabradine in Heart Failure

Ain Shams University

Status: Unknown

Conditions: Decompensated Heart Failure; Heart Failure With Reduced Ejection Fraction

Treatments: Drug: Ivabradine; Drug: Bisoprolol

Study type: Interventional

Funder types: Other

Identifiers

NCT03701880

ClinicalPH110

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Ivabradine group

Experimental group

Description:

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.

Treatment:

Drug: Bisoprolol

Drug: Ivabradine

Control group

Active Comparator group

Description:

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.

Treatment:

Drug: Bisoprolol

Drug: Ivabradine