Suspended

IvabradineEarly Ivabradine and Beta-Blocker Treatment Impact on Decompensated Heart Failure

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Study Aim

This study aims to evaluate the impact of early treatment with Ivabradine and Beta-Blockers on decompensated heart failure, by measuring the serum Pro-BNP level, which is an indicator of disease severity and clinical outcomes.

What is being tested

Ivabradine

+ Bisoprolol

Drug
Who is being recruted

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2018
See protocol details

Summary

Principal SponsorAin Shams University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 16, 2018

Actual date on which the first participant was enrolled.

This study focuses on the effects of a medication called Ivabradine on Egyptian patients with a heart condition known as heart failure with reduced ejection fraction (rEF HF). The main goal is to determine if early use of Ivabradine alongside B-blockers can improve clinical outcomes and biomarkers associated with this condition. The study is important as it aims to find better treatment approaches for heart failure, potentially improving patients' quality of life and reducing the risk of severe symptoms and complications. During the study, participants are randomly assigned to one of two groups. One group receives early treatment with Ivabradine and B-blockers, while the other follows the American Heart Association's standard treatment guidelines for rEF HF. The study measures various aspects such as heart rate, blood pressure, symptoms of breathlessness, and orthopnea. It also assesses the NYHA class, serum levels of Pro-NT-BNP and ST2, left ventricular ejection fraction through echocardiography, and scores from the Minnesota Living with Heart Failure Questionnaire. These assessments are conducted at the beginning, after 2 weeks, and again after 3 months. The primary outcome of interest is the serum Pro-BNP level, which is an indicator of heart failure severity and can suggest worse clinical outcomes and increased mortality risk in heart failure patients.

Official TitleThe Impact of Ivabradine Administration on Clinical Outcome and Biomarkers of Decompensated Heart Failure
NCT03701880
Principal SponsorAin Shams University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
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 II

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

El Demerdash Hospital

Cairo, EgyptOpen El Demerdash Hospital in Google Maps
SuspendedOne Study Center