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

NCT ID: NCT03710057

Last Updated: 2018-10-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-01
• Study Completion Date: 2017-05-15

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

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.

Conditions

Chronic Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Getz Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Dr. Fawad Farooq

Assistant Professor, Consultant Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

GTZ-CVD-001

Identifier Type: -

Identifier Source: org_study_id