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Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04448899
Study type Interventional
Source Damanhour University
Contact
Status Completed
Phase Phase 4
Start date June 1, 2020
Completion date February 5, 2021

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