Early Use of Ivabradine in Heart Failure

Heart Failure With Reduced Ejection Fraction Clinical Trial

— Ivabradine  

Official title:

The Impact of Ivabradine Administration on Clinical Outcome and Biomarkers of Decompensated Heart Failure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03701880
• Other study ID #: ClinicalPH110
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 16, 2018
• Est. completion date: December 23, 2019

Study information

• Verified date: October 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 23, 2019
• Est. primary completion date: December 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Decompensated Heart Failure
• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

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
• Bisoprolol
Bisoprolol is beta-blocker

Locations

Country	Name	City	State
Egypt	El Demerdash Hospital	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Ain Shams University	Sadat City University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum Pro-BNP level	Elevated NT-proBNP parallel HF disease severity and it is suggestive of worse clinical outcomes and mortality in HF	3 months
Secondary	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	3 months
Secondary	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	3 months of follow-up.
Secondary	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	3 months
Secondary	Heart rate	Measuring heart rate	3 months
Secondary	Left ventricular ejection fraction assessment	Two-dimensional echocardiogram coupled with Doppler flow studies will be performed	3 months
Secondary	Blood pressure	Measuring systolic and diastolic blood pressure	3 months