IvabradineEarly Ivabradine and Beta-Blocker Treatment Impact on Decompensated Heart Failure
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.
Ivabradine
+ Bisoprolol
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy 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