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

Sponsor

Getz Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT03710057

Collaborator

(none)

Enrollment

5.4

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Heart Failure	Drug: Ivabradine

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 1, 2016

Actual Primary Completion Date :

Feb 14, 2017

Actual Study Completion Date :

May 15, 2017

Outcome Measures

Primary Outcome Measures

Mean difference of Heart Rate [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 Outcome Measures

Percentage of problems reported in EQ-5D descriptive system [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'.
Median score of EQ-5D visual analogue scale [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 Outcome Measures

Percentage of Reported Adverse Drug Reactions [upto 8 weeks]
The pre-defined secondary outcome was to determine Safety and tolerability by monitoring adverse drug reactions.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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