Skip to main content
OpenTrials
Completed

NCT Number: NCT03710057

Effect of Ivabradine in Lowering Heart Rate and Quality of Life in Chronic Heart Failure Patients

Elevated Heart rate (HR) (≥ 70 bpm) is one of the contributing factors in increasing the burden of hospitalization among Heart Failure patient. Ivabradine is a novel, selective and specific in inhibiting a Funny current in sinoatrial node Node and approved as an alternative therapy for Chronic Heart Failure (CHF) patients. CHF patients when treated with Ivabradine reported 39%, and 30% reduction in mortality and hospitalization rate respectively. Patient were treated with Ivabradine 5mg twice daily to determine its effect in lowering Heart rate and the Quality of Life (QOL) in Chronic Heart Failure patients

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Heart Failure

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Observational

About this study

A prospective, post-marketing observational study was conducted in 50 chronic heart failure patients with age 30-70yrs of NYHA Class II and prescribed 5 mg Ivabradine twice daily. Heart rate was evaluated through ECG & quality of life was measured by a validated questionnaire EuroQol-5 Dimension 3 level version (EQ-5D-3L). Baseline demographic includes age, gender, height, weight, Body Mass Index, temperature, blood pressure and respiratory rate were recorded and patients were followed at week 4 and week 8. Safety and tolerability was assessed by adverse drug reaction (ADR) monitoring. Results were analyzed by statistical software SPSS version 20.0.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent
  • Known case of Chronic Heart Failure (New York Heart Association (NYHA) functional class II to III)
  • Clinically stability (at least for 4 weeks)
  • Resting heart rate of more than 70 beats/ min (bpm) as assessed from the 12-lead electrocardiogram.

Exclusion criteria

  • Hypersensitivity to the active substance or to any of the excipients
  • Resting heart rate below 70 beats per minute prior to treatment
  • Cardiogenic shock
  • Acute myocardial infarction
  • Severe hypotension (< 90/50 mmHg)
  • Severe hepatic insufficiency
  • Sick sinus syndrome
  • Sino-atrial block
  • Unstable or acute heart failure
  • Pacemaker dependent (heart rate imposed exclusively by the pacemaker)
  • Unstable angina
  • Atrioventricular Block of 3rd degree
  • The combination with a strong cytochrome P450 3A4 inhibitors such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone
  • The combination with verapamil or diltiazem which are moderate CYP3A4 inhibitors with heart rate reducing properties.
  • Pregnancy, lactation and women of child-bearing potential not using appropriate contraceptive measures

Treatment and study plan

Ivabradine

Drug

A prospective, post-marketing observational study was conducted in National Institute of cardiovascular disease, Karachi-Pakistan. Total 50 patients were advised to take 5 mg Ivabradine (SIVAB) twice daily for 8 weeks.

Primary outcomes

  1. Mean difference of Heart Rate

    Time frame: at 4 week and 8 week

    The primary end-point was the overall response rate of patients to Ivabradine in achieving HR <70 Bpm

Secondary outcomes

  1. Percentage of problems reported in EQ-5D descriptive system

    Time frame: at 4 week and 8 week

    Quality of Life was determined through validated questionnaire EQ-5D-3L. It also assesses five dimensions of HR quality of life (HRQoL): mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension is measured one to three levels i.e 1, 2, 3. Where level 2 & 3 indicates 'problem' and level 1 denotes to 'no problem'.

  2. Median score of EQ-5D visual analogue scale

    Time frame: at 4 week and 8 week

    The EQ-5D registers the self-rated health status of the respondent on the vertically visual analogue scale (EQ-5D VAS) from 0 to 100 where 100 indicates 'Best imaginable health' and 0 is said to be a 'Worst imagine health state'.

Other outcomes

  1. Percentage of Reported Adverse Drug Reactions

    Time frame: upto 8 weeks

    The pre-defined secondary outcome was to determine Safety and tolerability by monitoring adverse drug reactions.

Sponsors and collaborators

Lead sponsor

Getz Pharma

Industry

Registry information

Official study title

A Post-Marketing, Prospective, Observational Program: Effect of Ivabradrine in Lowering Heart Rate and Quality of Life in Chronic Heart Failure Patients

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 17, 2018
Registry last updated
Oct 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.