Ivabradine in Patients With Congestive Heart Failure

August 3, 2021 updated by: Rehab Werida, Damanhour University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • El-Gharbia
      • Tanta, El-Gharbia, Egypt, 31527
        • Tanta University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ivabradine

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.
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.
Other Names:
  • Procoralan 5 mg film-coated tablets
Placebo Comparator: Control
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.
Drug: Blacebo plus standard treatment
Blacebo plus standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NT-Pro BNP
Time Frame: three months
Serum BNP (pg/ml)
three months
Neopterin
Time Frame: three months
Serum Neopterin (nmol/L)
three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate
Time Frame: Three Months
Heart Rate (Beat/Minute)
Three Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damanhour University

Investigators

  • Study Director: Rehab Werida, Lecturer, Damanhour University, Faculty of Pharmacy
  • Principal Investigator: Jayda M Dogheim, B. Pharm, Alexandria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

February 1, 2021

Study Completion (Actual)

February 5, 2021

Study Registration Dates

First Submitted

June 24, 2020

First Submitted That Met QC Criteria

June 24, 2020

First Posted (Actual)

June 26, 2020

Study Record Updates

Last Update Posted (Actual)

August 4, 2021

Last Update Submitted That Met QC Criteria

August 3, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ivabradine in CHF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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