NCT04448899

Ivabradine in Patients With Congestive Heart Failure

Effects of Ivabradine on Neopterin and NT-Pro BNP in Patients With Congestive Heart Failure

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Damanhour University · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to assess the efficacy of Ivabradine therapy in patients with congestive heart failure using the cardiac biomarkers NT-Pro BNP and Neopterin.

Detailed description

* Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University * All participants have agreed to take part in this clinical study and provide informed consent * A 3 months, prospective interventional study. * Sixty ambulatory, clinically stable symptomatic patients with systolic chronic HF (≥ 4 weeks), on optimized standard medical therapy were consecutively included and randomly allocated to the ivabradine group (n=30) and non-ivabradine group (n=30). * The baseline evaluation comprised physical examination, NYHA class, 12-lead electrocardi¬ography (ECG), Echocardiography, blood sampling for laboratory measurements, including NT-Pro BNP and Neopterin. * Patients in the Ivabradine group were administered Ivabradine 5 mg twice daily and doses (2.5, 5, 7.5 mg) were to be adjusted upwards or downwards at every visit according to HR at rest and tolerability. * Patients were followed up after 1 week of initiation of ivabradine therapy then monthly till the end of the study. * Peripheral venous blood samples were drawn between 8 and 9 am after a 30-min rest in the supine position. Serum samples were frozen at -80°C until assay. * Levels of NT-Pro BNP and Neopterin were detected using ELISA kits as prescribed by manufacturer. * Statistical tests appropriate to the study will be conducted to evaluate significance of results * Results, conclusion, discussion and recommendations will be given

Conditions

• Congestive Heart Failure

Interventions

Type	Name	Description
DRUG	Ivabradine Oral Tablet	Ivabradine 5 mg twice daily and doses (2.5, 5, 7.5 mg) were to be adjusted upwards or downwards at every visit according to HR at rest and tolerability plus their standard treatment.
DRUG	Blacebo plus standard treatment	Blacebo plus standard treatment

Timeline

• Start date: 2020-06-01
• Primary completion: 2021-02-01
• Completion: 2021-02-05
• First posted: 2020-06-26
• Last updated: 2021-08-04

Locations

1 site across 1 country: Egypt