Ignite Creation Date:
2024-05-06 @ 12:16 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03710057
Status:
COMPLETED
Last Update Posted:
2018-10-17
First Post:
2018-10-11
Brief Title:
Effect of Ivabradine in Lowering Heart Rate and Quality of Life in Chronic Heart Failure Patients
Sponsor:
Getz Pharma
Organization:
Getz Pharma
Study Overview
Official Title:
A Post-Marketing Prospective Observational Program Effect of Ivabradrine in Lowering Heart Rate and Quality of Life in Chronic Heart Failure Patients
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
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:
None
Brief Summary:
Elevated Heart rate HR 70 bpm is one of the contributing factors in increasing the burden of hospitalization among Heart Failure patient Ivabradine is a novel selective and specific in inhibiting a Funny current in sinoatrial node Node and approved as an alternative therapy for Chronic Heart Failure CHF patients CHF patients when treated with Ivabradine reported 39 and 30 reduction in mortality and hospitalization rate respectively Patient were treated with Ivabradine 5mg twice daily to determine its effect in lowering Heart rate and the Quality of Life QOL in Chronic Heart Failure patients
Detailed Description:
A prospective post-marketing observational study was conducted in 50 chronic heart failure patients with age 30-70yrs of NYHA Class II and prescribed 5 mg Ivabradine twice daily Heart rate was evaluated through ECG quality of life was measured by a validated questionnaire EuroQol-5 Dimension 3 level version EQ-5D-3L Baseline demographic includes age gender height weight Body Mass Index temperature blood pressure and respiratory rate were recorded and patients were followed at week 4 and week 8 Safety and tolerability was assessed by adverse drug reaction ADR monitoring Results were analyzed by statistical software SPSS version 200
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