Ivabradine in Patients With Congestive Heart Failure

Congestive Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04448899
• Other study ID #: Ivabradine in CHF
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2020
• Est. completion date: February 5, 2021

Study information

• Verified date: August 2021
• Source: Damanhour University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 5, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

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.
• Blacebo plus standard treatment
Blacebo plus standard treatment

Locations

Country	Name	City	State
Egypt	Tanta University Hospital	Tanta	El-Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Damanhour University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Komajda M, Tavazzi L, Francq BG, Böhm M, Borer JS, Ford I, Swedberg K; SHIFT Investigators. Efficacy and safety of ivabradine in patients with chronic systolic heart failure and diabetes: an analysis from the SHIFT trial. Eur J Heart Fail. 2015 Dec;17(12) — View Citation

Richards M, Troughton RW. NT-proBNP in heart failure: therapy decisions and monitoring. Eur J Heart Fail. 2004 Mar 15;6(3):351-4. Review. — View Citation

Sasaki T, Takeishi Y, Suzuki S, Niizeki T, Kitahara T, Katoh S, Ishino M, Shishido T, Watanabe T, Kubota I. High serum level of neopterin is a risk factor of patients with heart failure. Int J Cardiol. 2010 Nov 19;145(2):318. doi: 10.1016/j.ijcard.2009.11 — View Citation

Tavazzi L, Swedberg K, Komajda M, Böhm M, Borer JS, Lainscak M, Ford I; SHIFT Investigators. Efficacy and safety of ivabradine in chronic heart failure across the age spectrum: insights from the SHIFT study. Eur J Heart Fail. 2013 Nov;15(11):1296-303. doi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NT-Pro BNP	Serum BNP (pg/ml)	three months
Primary	Neopterin	Serum Neopterin (nmol/L)	three months
Secondary	Heart Rate	Heart Rate (Beat/Minute)	Three Months