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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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 is beta-blocker
El Demerdash Hospital
Cairo, Egypt
serum Pro-BNP level
Elevated NT-proBNP parallel HF disease severity and it is suggestive of worse clinical outcomes and mortality in HF
Time frame: 3 months
ST2 serum level
Repeated ST2 measurements appeared to be a strong predictor of outcome especially in patients with acute HF. Also, ST2 levels in patients with acute HF are significantly higher than in patients with chronic HF and fall rapidly over days to weeks during HF treatment. This lack of reduction in ST2 level during acute HF treatment is predictive of mortality. So, persistently high levels of ST2 were associated with increased mortality risk
Time frame: 3 months
The effect on patient quality of life using Minnesota Living with Heart Failure Questionnaire
The questionnaire is comprised of 21 important physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. the patient marks a 0 (zero) to 5 scale to indicate how much each itemized adverse of heart failure has prevented the patient from living as he or she wanted to live during the past 4 weeks. it is simply scored by summation of all 21 responses.The simple sum of the responses that ranges from 0 to 105 is a measurement of heart failure severity as indicated by its adverse effect on the respondent's life during the past month
Time frame: 3 months of follow-up.
NYHA class assessment
This classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath
Time frame: 3 months
Heart rate
Measuring heart rate
Time frame: 3 months
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Left ventricular ejection fraction assessment
Two-dimensional echocardiogram coupled with Doppler flow studies will be performed
Time frame: 3 months
Blood pressure
Measuring systolic and diastolic blood pressure
Time frame: 3 months