Effect of Ivabradine in Lowering Heart Rate and Quality o... | NCT03710057

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

NCT03710057

Sponsor

Getz Pharma

Status

Completed

Last Update Posted

Oct 17, 2018Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Chronic Heart Failure

Interventions

Ivabradine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2016Actual

Primary Completion Date

Feb 14, 2017Actual

Completion Date

May 15, 2017Actual

First Submitted Date

Oct 11, 2018

First Submission Date that Met QC Criteria

Oct 16, 2018

First Posted Date

Oct 17, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 16, 2018

Last Update Posted Date

Oct 17, 2018Actual

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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'.

Other Outcomes

Measure	Description	Time Frame
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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

ID	Term
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds