Early Use of Ivabradine in Heart Failure
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
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:
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Physical examination (heart rate, blood pressure, dyspnea and orthopnea symptoms)
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NYHA class
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Pro-NT-BNP serum level, ST2 serum level
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Echocardiography (left ventricular ejection fraction)
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Score of Minnesota Living with Heart Failure Questionnaire these objectives will be measured baseline, 2 weeks and after 3 months
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: 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
Other Names:
Drug: Bisoprolol
Bisoprolol is beta-blocker
Other Names:
|
| Active Comparator: 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. |
Drug: 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
Other Names:
Drug: Bisoprolol
Bisoprolol is beta-blocker
Other Names:
|
Outcome Measures
Primary Outcome Measures
- serum Pro-BNP level [3 months]
Elevated NT-proBNP parallel HF disease severity and it is suggestive of worse clinical outcomes and mortality in HF
Secondary Outcome Measures
- ST2 serum level [3 months]
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
- The effect on patient quality of life using Minnesota Living with Heart Failure Questionnaire [3 months of follow-up.]
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
- NYHA class assessment [3 months]
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
- Heart rate [3 months]
Measuring heart rate
- Left ventricular ejection fraction assessment [3 months]
Two-dimensional echocardiogram coupled with Doppler flow studies will be performed
- Blood pressure [3 months]
Measuring systolic and diastolic blood pressure
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient with acute heart failure either newly diagnosed or decompensated heart failure after stabilization
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Patients > 18 years old
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Left ventricular ejection fraction less than 40 % of presumed irreversible etiology
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Clinically stable 24-48 hours after admission
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Sinus rhythm with heart rate above 70 bpm
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No previous treatment with ivabradine
Exclusion Criteria:
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Patients less than 18 years.
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Arterial fibrillation before inclusion.
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Ventricular dysfunction due to acute event (Myocarditis, AMI). 4- cardiogenic shock
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Patients are taking drug interact with ivabradine. 6- carrier or candidate for pacemaker, heart transportation, cardiac surgery or other cardiovascular procedure
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | El Demerdash Hospital | Cairo | Egypt |
Sponsors and Collaborators
- Ain Shams University
- Sadat City University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ClinicalPH110