Ignite Creation Date:
2024-05-06 @ 12:12 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03701880
Status:
UNKNOWN
Last Update Posted:
2018-10-11
First Post:
2018-10-08
Brief Title:
Early Use of Ivabradine in Heart Failure
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
The Impact of Ivabradine Administration on Clinical Outcome and Biomarkers of Decompensated Heart Failure
Status:
UNKNOWN
Status Verified Date:
2018-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Ivabradine
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 fractionrEF 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None