Ivabradine in Patients With Congestive Heart Failure

Phase 4

Completed

• Conditions: Congestive Heart Failure
• Interventions: Drug: Ivabradine Oral Tablet; Drug: Blacebo plus standard treatment

• Registration Number: NCT04448899
• Lead Sponsor: Damanhour University

Brief 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

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2020-06-24
• Study First Submitted QC: 2020-06-24
• Study First Posted: 2020-06-26
• Primary Completion: 2021-02-01
• Study Completion: 2021-02-05
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-03
• Last Update Posted: 2021-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients with chronic HF, on optimized medical therapy according to European Society of Cardiol¬ogy guidelines, with LV ejection fraction (LVEF) < 35% according to the Simpson method, New York Heart Association (NYHA) class II-III, and sinus rhythm and resting HR > 70/min were eligible for inclusion in the study.

Exclusion Criteria

• acute decompen¬sation (acute coronary syndromes and acute HF);
• hemodynamically significant valve disease;
• cer¬ebrovascular events during the previous 6 months;
• dysfunctional prosthetic heart valve;
• obstructive or non-obstructive cardiomyopathy; uncorrected congenital heart disease; active myocarditis;
• a his¬tory of resuscitation from sudden death; an absence of stable sinus rhythm, severe arrhythmias; HR < 60 bpm; sick sinus syndrome; second-degree and third-degree atrioventricular block;
• severe obesity (body mass index > 36 kg/m²);
• established or sus¬pected pulmonary diseases (vital capacity < 80% or forced expiratory volume in 1 s < 80% of age spe¬cific and sex-specific reference values);
• hemoglobin ≤ 11 g/dL;
• treatment with non-dihydropyridine calcium-channel blockers, class I antiarrhythmic agents, strong inhibitors of cytochrome P450-3A4, or QT interval-prolonging medications;
• acute and chronic kidney failure;
• pregnancy; hypo- and hy¬perthyroidism or acute infections.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ivabradine	Ivabradine Oral Tablet	Patients 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.
Control	Blacebo plus standard treatment	Patients administered a placebo twice daily. Patients were followed up after 1 week of initiation of the study then monthly till the end of the study.

Primary Outcome Measures

Name	Time	Method
Neopterin	three months	Serum Neopterin (nmol/L)
NT-Pro BNP	three months	Serum BNP (pg/ml)

Secondary Outcome Measures

Name	Time	Method
Heart Rate	Three Months	Heart Rate (Beat/Minute)

Trial Locations

Locations (1)

Tanta University Hospital; 🇪🇬 Tanta, El-Gharbia, Egypt