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

Chronic Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03710057
• Other study ID #: GTZ-CVD-001
• Status: Completed
• Start date: December 1, 2016
• Est. completion date: May 15, 2017

Study information

• Verified date: October 2018
• Source: Getz Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 15, 2017
• Est. primary completion date: February 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Drug:
• Ivabradine
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Getz Pharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Reported Adverse Drug Reactions	The pre-defined secondary outcome was to determine Safety and tolerability by monitoring adverse drug reactions.	upto 8 weeks
Primary	Mean difference of Heart Rate	The primary end-point was the overall response rate of patients to Ivabradine in achieving HR <70 Bpm	at 4 week and 8 week
Secondary	Percentage of problems reported in EQ-5D descriptive system	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'.	at 4 week and 8 week
Secondary	Median score of EQ-5D visual analogue scale	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'.	at 4 week and 8 week