A Study to determine the impact of IVABID once a day in patients with management of heart failure.

Phase 4

Completed

• Conditions: Health Condition 1: I502- Systolic (congestive) heart failure

• Registration Number: CTRI/2022/01/039529
• Lead Sponsor: Abbott Healthcare Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-12-30
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 500

Inclusion Criteria

1.Male & female patients with Age >= 18 years at Enrollment Visit /Visit 1

2.Patients with Stable chronic HF of NYHA Class II to III at the time of screening being managed at outpatient basis

3.Patients with chronic heart failure with systolic dysfunction who are being managed with Ivabid® OD as per the approved label.

Exclusion Criteria

1.Patients with following conditions:

•Hypersensitivity to the active substance or to any of the excipient

•Acute decompensated heart failure

•Pacemaker dependent (heart rate imposed exclusively by the pacemaker)

•Resting heart rate below 60 bpm before treatment

•Severe hepatic impairment

•Severe hypotension (less than 90/50 mm Hg)

•Sick sinus syndrome, sinoatrial block, or third-degree atrioventricular block, except in presence of functioning demand pacemaker

2.Patients of Heart failure who are currently admitted in the hospital

3.Patients with Myocardial infarction or coronary revascularization within previous 2 months

4.Patients with planned or history of heart transplant, Left Ventricular Assist Device (LVAD) or dialysis

5.Patients with Major recurrent life-threatening cardiac arrhythmia

6.Patients with implantable cardiac device like pacemaker and defibrillator

7.Patients with Atrial Fibrillation

8.Patients with history of terminal renal/hepatic/pulmonary disease

9.Patients as a part of any other clinical study on an Investigational Product

10.Patients with any other conditions or diseases that investigator considers it as inappropriate to enter the study as per prescribing information.

11.Patient presenting any COVID infection Symptoms or are tested COVID positive during the enrollment visit or during the conduct of the study will be excluded from the study

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the impact of IVABID OD on average resting HR from Visit 1 (Enrollment Visit /Visit 1, Day 0) to Visit 5 (End of Study, 12 months) in patients with reduced ejection fraction with systolic dysfunction.Timepoint: Change in average resting heart rate from Visit 1 (Enrollment Visit /Visit 1, Day 0) to Visit 5 (End of Study, 12 months)

Secondary Outcome Measures

Name	Time	Method
To determine the impact of IVABID OD on average resting HR at each visit <br/ ><br>To study the clinical outcomes of Cardiovascular death, Hospitalization for worsening heart failure and all-cause mortality during the study period in patients with HF <br/ ><br>To understand the usage pattern of heart rate lowering medications along with IVABID OD (once daily) during the study period. <br/ ><br>To evaluate safety of patients with HF during the study period.Timepoint: Change in the average resting HR at each visit from baseline <br/ ><br>Number of patients undergoing change (addition/ deletion of class of drug, change of drug within the same class) in heart rate lowering medications during the study period <br/ ><br>Number and proportions of adverse events pertaining to heart rate lowering medications [Adverse Drug Reactions (ADRs) & or serious adverse drug reactions (SADRs) <br/ ><br>Visit 1 (Enrollment Visit /Visit 1, Day 0) to Visit 5 (End of Study, 12 months)