NCT03710057

Effect of Ivabradine in Lowering Heart Rate and Quality of Life in Chronic Heart Failure Patients

A Post-Marketing, Prospective, Observational Program: Effect of Ivabradrine in Lowering Heart Rate and Quality of Life in Chronic Heart Failure Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Getz Pharma · Industry
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

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 20.0.

Conditions

• Chronic Heart Failure

Interventions

Type	Name	Description
DRUG	Ivabradine	A prospective, post-marketing observational study was conducted in National Institute of cardiovascular disease, Karachi-Pakistan. Total 50 patients were advised to take 5 mg Ivabradine (SIVAB) twice daily for 8 weeks.

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-02-14
• Completion: 2017-05-15
• First posted: 2018-10-17
• Last updated: 2018-10-17