search
Back to results

Early Use of Ivabradine in Heart Failure (Ivabradine)

Primary Purpose

Heart Failure With Reduced Ejection Fraction, Decompensated Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ivabradine
Bisoprolol
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure With Reduced Ejection Fraction focused on measuring Decompensated Heart Failure, Ivabradine, ST2 Biomarker

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • El Demerdash Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ivabradine group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

serum Pro-BNP level
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
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
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
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
Measuring heart rate
Left ventricular ejection fraction assessment
Two-dimensional echocardiogram coupled with Doppler flow studies will be performed
Blood pressure
Measuring systolic and diastolic blood pressure

Full Information

First Posted
October 8, 2018
Last Updated
October 9, 2018
Sponsor
Ain Shams University
Collaborators
Sadat City University
search

1. Study Identification

Unique Protocol Identification Number
NCT03701880
Brief Title
Early Use of Ivabradine in Heart Failure
Acronym
Ivabradine
Official Title
The Impact of Ivabradine Administration on Clinical Outcome and Biomarkers of Decompensated Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 16, 2018 (Actual)
Primary Completion Date
December 23, 2019 (Anticipated)
Study Completion Date
December 23, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
Collaborators
Sadat City University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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: Physical examination (heart rate, blood pressure, dyspnea and orthopnea symptoms) NYHA class Pro-NT-BNP serum level, ST2 serum level Echocardiography (left ventricular ejection fraction) Score of Minnesota Living with Heart Failure Questionnaire these objectives will be measured baseline, 2 weeks and after 3 months

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Reduced Ejection Fraction, Decompensated Heart Failure
Keywords
Decompensated Heart Failure, Ivabradine, ST2 Biomarker

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ivabradine group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ivabradine
Other Intervention Name(s)
Procoralan
Intervention Description
Ivabradine is pacemaker current I(f) inhibitor thereby slowing heart rates without exhibiting negative inotropic effect on the myocardium or altering ventricular action potential
Intervention Type
Drug
Intervention Name(s)
Bisoprolol
Other Intervention Name(s)
concor
Intervention Description
Bisoprolol is beta-blocker
Primary Outcome Measure Information:
Title
serum Pro-BNP level
Description
Elevated NT-proBNP parallel HF disease severity and it is suggestive of worse clinical outcomes and mortality in HF
Time Frame
3 months
Secondary Outcome Measure Information:
Title
ST2 serum level
Description
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
Title
The effect on patient quality of life using Minnesota Living with Heart Failure Questionnaire
Description
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.
Title
NYHA class assessment
Description
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
Title
Heart rate
Description
Measuring heart rate
Time Frame
3 months
Title
Left ventricular ejection fraction assessment
Description
Two-dimensional echocardiogram coupled with Doppler flow studies will be performed
Time Frame
3 months
Title
Blood pressure
Description
Measuring systolic and diastolic blood pressure
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with acute heart failure either newly diagnosed or decompensated heart failure after stabilization Patients > 18 years old Left ventricular ejection fraction less than 40 % of presumed irreversible etiology Clinically stable 24-48 hours after admission Sinus rhythm with heart rate above 70 bpm No previous treatment with ivabradine Exclusion Criteria: Patients less than 18 years. Arterial fibrillation before inclusion. 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
Facility Information:
Facility Name
El Demerdash Hospital
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

Early Use of Ivabradine in Heart Failure

We'll reach out to this number within 24 hrs