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

Not yet recruiting

• Conditions: Combined systolic (congestive) anddiastolic (congestive) heart failure,

• Registration Number: CTRI/2019/02/017452
• Lead Sponsor: Sun Pharma Laboratories Limited

Brief Summary

This is randomized, double blind, double dummy, parallel,multi-centric, comparative phase IIIclinical study to evaluate efficacy and safety of Ivabradine Extended Release Tablets in comparison to Ivabradine Tablets in patients withstable chronic heart failure with systolic dysfunction. Male or female 160 patients (80 patients per group) with agebetween 18 to 65 years, on stable dose of Ivabradine Tablets 5 mg/ 7.5 mg BDsince ≥ 4 weeks for stable chronic heart failure with systolic dysfunction. Total study duration of 14 weeks will consistof 07 visits including: one screening visit, Run in period, one Randomization Visit, three follow-up visits and endof the study visit. Efficacy analysis will be assessed by change in resting heart rate from baseline to 12 weeks.

PrimaryEndpoint(s)Primary Efficacy Outcome measurewill be:

1. Change in resting heart rate from baseline [Timeframe: 12 weeks]

(Restingheart rate will be assessed by taking 3 consecutive ECGs taken by automated 12Lead ECG within 30 minutes after approximately 5-10 minutes of initial restprior to first ECG recording)

Secondary Endpoint(s)1. Secondary Safety Outcome measure will be:

Ø  Proportionof participants with adverse events and serious adverse events [Time frame: 12weeks]

*2. Exploratory endpoints*

Incidence for hospitalizations for worsening HF, otherCV reasons or all-cause mortality from baseline to 12 weeks

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-15
• Last Update Posted: 2019-05-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 160

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:	12 weeks
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)	12 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary Safety Outcome measure:	Proportion of participants with adverse events and serious adverse events
Exploratory endpoints	Incidence for hospitalizations for worsening HF, other CV reasons or all-cause mortality from baseline

Trial Locations

Locations (6)

IMS & SUM Hospital; 🇮🇳 Khordha, ORISSA, India

King Georges Medical University; 🇮🇳 Lucknow, UTTAR PRADESH, India

Maxcure Hospitals; 🇮🇳 Hyderabad, TELANGANA, India

Osmania Medical College/ Osmania General Hospital; 🇮🇳 Hyderabad, TELANGANA, India

Oyster & Pearl Hospitals; 🇮🇳 Pune, MAHARASHTRA, India

SMS Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

IMS & SUM Hospital

🇮🇳Khordha, ORISSA, India

Dr Behera Kumar Gouraba

Principal investigator

917528948833

dr.kumargaurav137@icloud.com