A clinical trial to study the efficacy and safety Ivabradine Extended Release Tablets in comparison to Ivabradine Tablets in patients with stable chronic heart failure with systolic dysfunction in India

Phase 3

Conditions: Health Condition 1: I504- Combined systolic (congestive) anddiastolic (congestive) heart failure

Registration Number: CTRI/2019/02/017452

Lead Sponsor: Sun Pharma Laboratories Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Male or female patient aged between 18 and 65 years (both inclusive)

2.Patient who is on stable dose of Ivabradine Tablets 5 mg/ 7.5 mg BD since >= 4 weeks for stable chronic heart failure with systolic dysfunction

3.Patient concurrently receiving standard care for stable chronic heart failure (as per recommendation 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure)

4.Patient with stable chronic heart failure of NYHA class II to III for >= 4 weeks at the time of screening

5.Patient with sinus rhythm with clinically stable HR > 50 bpm as assessed by automated standard 12 Lead ECG

6.Patient with LVEF <= 40 % at screening

7.Patient willing to give informed consent and follow the study protocol

8.Patient with no physical limitation to ingest and retain oral medication

9.Female patient of childbearing potential must be willing to use acceptable method of contraception (female of childbearing potential is defined as one who has not been postmenopausal for at least one year, or has not been surgically sterilized, or has not had a hysterectomy at least three months prior to the start of this study). Acceptable method of contraception includes (e.g. barrier method with spermicide). The calendar method, withdrawal, or an IUD is NOT an acceptable method AND women if postmenopausal (aged greater than 45 years) must have a history of amenorrhea for at least 1 year from the time of last menstrual cycle.

Exclusion Criteria

1.Patient with history of pacemaker, heart transplantation or on list of heart transplantation

2.Patient with recent (<= 3 months prior to screening) history of MI, coronary revascularization, stroke, or transient ischemic attack

3.Patient with history of implantable cardioverter defibrillator, or cardiac resynchronization therapy within previous 6 months of screening

4.Patient scheduled for coronary revascularization, or likely to require surgery for valvular disease during the study period

5.Patient with permanent atrial fibrillation or flutter or any other cardiac arrhythmias which may interfere with function of sinoatrial node

6.Patient with sick sinus syndrome, sinoatrial block, congenital long QT or treated with QT prolonging medications, 2nd, 3rd degree and complete atrioventricular block

7.Patient with any cardiac condition which does not justify the inclusion of the patient in the study as per investigator discretion (e.g. acute decompensated heart failure, severe primary valvular disease, active myocarditis, congenital heart disease, peripartum cardiomyopathy etc.)

8.Patient with stroke or transient cerebral ischemia within previous <= 3 months prior at screening

9.Patient with current history of unstable or acute HF, unstable angina

10.Patient with severe or uncontrolled hypertension (seated systolic BP [SBP] >= 190 mmHg or seated diastolic BP [DBP] >= 110 mmHg) uncontrolled hypotension (seated SBP <= 90 mmHg or seated DBP <= 50 mmHg)

11.Patient with type 2 diabetes (HbA1c >= 7%) at screening

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Outcome measure: <br/ ><br>Change in resting heart rate from baseline (Resting heart rate will be assessed by taking 3 consecutive ECGs taken by automated 12 Lead ECG within 30 minutes after approximately 5-10 minutes of initial rest prior to first ECG recording)Timepoint: 12 weeks

Secondary Outcome Measures

Name	Time	Method
Exploratory endpoints <br/ ><br>Incidence for hospitalizations for worsening HF, other CV reasons or all-cause mortality from baselineTimepoint: 12 weeks;Secondary Safety Outcome measure: <br/ ><br>Proportion of participants with adverse events and serious adverse eventsTimepoint: 12 weeks