Health Condition 1: I504- Combined systolic (congestive) anddiastolic (congestive) heart failure
Conditions
Interventions
Intervention1: Test Drug 1: Ivabradine Extended Release Tablets 10 mg: Each patient will be receiving four tablets in a day (two in morning and two in evening). Patient will be
asked to take the medi
Sponsors
Sun Pharma Laboratories Limited
Eligibility
Inclusion criteria
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 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
Exclusion criteria: 1. Patient with history of pacemaker, heart transplantation or on list of heart transplantation 2. Patient with recent ( 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 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 11. Patient with type 2 diabetes (HbA1c >= 7%) at screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy Outcome measure: 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
| Measure | Time frame |
|---|---|
| Exploratory endpoints Incidence for hospitalizations for worsening HF, other CV reasons or all-cause mortality from baselineTimepoint: 12 weeks;Secondary Safety Outcome measure: Proportion of participants with adverse events and serious adverse eventsTimepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactGuruprasad Palekar
Deputy General Manager - India Clinical Research
Outcome results
None listed