Ivabradine in Patients With Congestive Heart Failure

Damanhour University

Status and phase: Completed; Phase 4

Conditions: Congestive Heart Failure

Treatments: Drug: Ivabradine Oral Tablet; Drug: Blacebo plus standard treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04448899

Ivabradine in CHF

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Ivabradine

Active Comparator group

Description:

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.

Treatment:

Drug: Ivabradine Oral Tablet

Control

Placebo Comparator group

Description:

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.

Treatment:

Drug: Blacebo plus standard treatment