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

NCT03710057 | Completed

• 1 other identifier: GTZ-CVD-001
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Conditions

Chronic Heart Failure

Keywords

Ivabradine; Heart Rate; Health Related Quality of Life; Safety; Chronic Heart Failure Patient

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percentage of problems reported in EQ-5D descriptive system

  at 4 week and 8 week

• Median score of EQ-5D visual analogue scale

  at 4 week and 8 week

Other Outcomes (1)

• Percentage of Reported Adverse Drug Reactions

  upto 8 weeks

Interventions

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.

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population was included male or female patients with Chronic Heart Failure (CHF). Diagnosis of CHF as per Boston Criteria for Diagnosing Heart failure and the New York Heart Association (NYHA) functional class II to III classification and rest on the based on the medical judgment of the investigator after review of subject's medical history, results of routine screening physical and general examination and routine laboratory investigations. Patients' written authorization was used to obtain patients' data. However, patient data secrecy was followed by ICH GCP requirements.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Getz Pharma: lead

MeSH Terms

Interventions

Ivabradine

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Consultant Cardiologist

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 17, 2018
• Study Start: December 1, 2016
• Primary Completion: February 14, 2017
• Study Completion: May 15, 2017
• Last Updated: October 17, 2018

Record last verified: 2018-10