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CTRI Number  CTRI/2018/04/013464 [Registered on: 24/04/2018] Trial Registered Prospectively
Last Modified On: 07/09/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   The Efficacy and Safety of Ivabradine Tablet in Patients with heart failure 
Scientific Title of Study   A Prospective, Randomized, Double-blind, Double dummy, Multi Centre, Comparative Phase III Clinical Trial to Evaluate the Efficacy and Safety of Ivabradine Prolonged Release Tablets in Patients with Stable Chronic Heart Failure with Systolic Dysfunction 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Protocol Number 1.1 dated 30 June 2017  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ajit Mullasari  
Designation  Director, Department of Cardiology 
Affiliation  The Madras Medical Mission 
Address  The Madras Medical Mission, No 4A, Dr. J.Jayalalitha Nagar, Mogappair, Chennai 600037

Chennai
TAMIL NADU
600037
India 
Phone  9841271361  
Fax  04426565974  
Email  clireco@mmm.org.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Shubhangi Desai  
Designation  Associate Director, Clinical Operations and Pharmacovigilance  
Affiliation  Abbott Healthcare Pvt. Ltd. 
Address  Department: Clinical Operations, Medical Affairs, Floor 16, Godrej BKC, Plot No. C68, BKC, Near MCA Club, Bandra (E) Mumbai400 051 India Mumbai MAHARASHTRA 400051 India

Mumbai
MAHARASHTRA
400051
India 
Phone  02238160918  
Fax    
Email  shubhangi.desai@abbott.com  
 
Details of Contact Person
Public Query  
Name  Dr Shubhangi Desai  
Designation  Associate Director, Clinical Operations and Pharmacovigilance  
Affiliation  Abbott Healthcare Pvt. Ltd. 
Address  Department: Clinical Operations, Medical Affairs, Floor 16, Godrej BKC, Plot No. C68, BKC, Near MCA Club, Bandra (E) Mumbai400 051 India Mumbai MAHARASHTRA 400051 India

Mumbai
MAHARASHTRA
400051
India 
Phone  02238160918  
Fax    
Email  shubhangi.desai@abbott.com  
 
Source of Monetary or Material Support  
Abbott Healthcare Private Limited Floor 18, Godrej BKC, Plot No. C – 68, BKC, Near MCA Club, Bandra (E) Mumbai – 400 051  
 
Primary Sponsor  
Name  Abbott Healthcare Private Limited  
Address  Floor 18, Godrej BKC, Plot No. C – 68, BKC, Near MCA Club, Bandra (E) Mumbai400 051 India  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 21  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ambuj Roy  All India Institute of Medical Sciences,Delhi  Cardiologist, Cardio Thoracic Sciences Centre All India Institute of Medical Sciences, Ansari Nagar New Delhi-110029
New Delhi
DELHI 		 91-11-26593861

drambujroy@gmail.com 
Dr Tejas Patel  Apex Heart Institute  Apex Heart Institute (A unit of TCVS PVT. Ltd.), Block G-K Mondeal Business Park, Near Gurudwara, S.G. Highway, Ahmadabad-380054. Gujarat, India
Ahmadabad
GUJARAT 		 0792684220

tejaspatel@apexheart.in 
Dr G Sengottuvelu  Apollo hospital enterprise ltd, Chennai  Consultant Cardiologist, Department of Cardiology, Apollo hospital enterprise ltd 21 Greams Road, Chennai-600006 Tamil Nadu, India
Chennai
TAMIL NADU 		 09841430999

drgseng@gmail.com 
Dr Dhiman Kahali  B.M. Birla Heart institute, Kolkata  senior Interventional Consultant Cardiologist, Department of Cardiology B.M Birla Heart Research Center 1/1 , National Library Avenue Kolkata -700027 West Bengal India
Kolkata
WEST BENGAL 		 9810075983

kahalidrdhiman@gmail.com 
Dr Upendra Kaul  Batra Heart Centre, Batra Hospital and Medical Research Centre  Chairman, Department of Cardiology Batra Heart Centre, Batra Hospital and Medical Research Centre, 1 Tughlakabad Institutional Area , Mehrauli Badarpur Road, New Delhi -110062
New Delhi
DELHI 		 9811150518

kaul.upendra@gmail.com 
Dr Subash Chandra  BLK Super Speciality Hospital, Delhi  Consultant Cardiologist, Department of Cardiology BLK Super Speciality Hospital Building No-5, Pusa Road, New Delhi-110005 India
New Delhi
DELHI 		 91-9810075983

dr_sc26@hotmail.com 
Dr Manoj Chopda  Chopda Medicare & Research Centre Pvt. Ltd, Nashik  Cardiologist, Chopda Medicare & Research Centre Pvt. Ltd., 3/5, Patil lane-1, Laxmi Nagar, Canada Corner, Nashik, Maharashtra, India
Nashik
MAHARASHTRA 		 09823021613

drchopdamanoj@gmail.com 
Dr Rakesh Kumar Aggarwal  Deep Heart Center, Ludhiana  Consultant Cardiologist, Cardiology Dept., Deep Heart Center 478 -1, Model Town Rd, Pritam Nagar, Model Town, Ludhiana, Punjab 141002, India
Ludhiana
PUNJAB 		 91-9814215692

aggarwal.rakeshkumar@yahoo.com 
Dr Mukul Misra  Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow  Dean, Professor & HOD, Department of Cardiology, Dr. Ram Manohar Lohia Institute of Medical Sciences Vibhutikhand, Gomtinagar, Lucknow-226010, UP, India
Lucknow
UTTAR PRADESH 		 91-9450959088

mukul_rk_misra@yahoo.com 
Dr Rajpal K Abhichand  G. Kuppuswamy Naidu Memorial Hospital  Interventional Cardiologist, Department of Cardiology, G.Kuppuswamy Naidu Memorial Hospital Post Box No: 6327, Nethaji Road, Pappanaickenpalayam, Coimbatore, Tamil Nadu-641037, India
Coimbatore
TAMIL NADU 		 9443272172

rka.trials@gmail.com 
Dr R V Vijay Bhaskar  Gleneagles Global Hospital, Hyderabad.  Senior Consultant Interventional Cardiologist, Department of Cardiology, Gleneagles Global 6-1-1070/1 To 4, Lakdikapool, Hyderabad- 500004, Telangana
Hyderabad
TELANGANA 		 9848016056

rvvijaybhaskar@rediffmail.com 
Dr Dinesha Basavanna  K. R Hospital, Mysore Medical College & Research Institute, Mysore  Consultant Cardiologist, Department of Cardiology, K. R Hospital, Mysore Medical College & Research Institute, Irwin Road, Mysore-570001, Karnataka
Mysore
KARNATAKA 		 9448413168

dr.dinesh@gmail.com 
Dr Milind Gadkari  KEM Hospital Research Center, Pune  Senior Interventional Cardiologist, Department of cardiology, KEM Hospital Research Center, Sardar Moodliar Road Rasta Peth, Pune 411 011 Maharashtra INDIA
Pune
MAHARASHTRA 		 09822030120
02066037522
gadkaris@gmail.com 
Dr Santanu Guha  Kolkata Medical College & Hospital, Kolkata  Cardiologist, Department of Cardiology, Kolkata Medical College & Hospital, 88, College Street, Kolkata, West Bengal-700073, India
Kolkata
WEST BENGAL 		 09831016367

guhas55@gmail.com 
Dr Rajendra Kumar Premchand  Krishna Institute of Medical Sciences, Secunderabad  Consultant interventional Cardiologist, Department of Cardiology, Krishna Institute of Medical Sciences, 1-8-31/1, Minister Road, Secunderabad-500003 Telangana, India
Hyderabad
ANDHRA PRADESH 		 91-9848029443

kumarpre@hotmail.com 
Dr Ajay Mahajan  LTMMC & LTMCH, Sion Mumbai  Cardiologist, Department of Cardiology, LTMMC & LTMCH, Medical College building 2nd floor, Dr B. R Ambedkar Road, Sion, Mumbai, Maharashtra- 400022 India
Mumbai
MAHARASHTRA 		 9920432639

draumahajan@gmail.com 
Dr Ajit Mullasari  Madras Medical Mission, Chennai  Consultant Cardiologist, Department of Cardiology, Madras Medical Mission 4/A, Dr JJ Nagar, Mogappair, Chennai-300037, Tamil Nadu, India
Chennai
TAMIL NADU 		 91-9841271361

clireco@mmm.org.in 
Dr B B Chanana  Maharaja Agrasen Hospital, Delhi  Consultant Cardiologist, Department of Cardiology, Maharaja Agrasen Hospital, West Punjabi Bagh, Near Shivaji Park Metro Station, Jain Muni Guru Ramkrishan Marg, Delhi, 110026, India
New Delhi
DELHI 		 91-9910109195

bbchanana@yahoo.com 
Dr Divyaprakash  PMSSY Superspeciality Hospital, Bangalore  Consultant Cardiologist, Department of Cardiology,PMSSY Superspeciality Hospital, Victoria Hospital Campus, BMCRI, KR Road, Bengaluru-560002, Karnataka, India
Bangalore
KARNATAKA 		 9845860473

drdivyaprakash.pmssy@gmail.com 
Dr Sudeep Kumar  Sanjay Gandhi PGIMS, Lucknow  Cardiologist, Department of Cardiology Sanjay Gandhi PGIMS Raibareli Road, Lucknow, UP-226014, India
Lucknow
UTTAR PRADESH 		 91-5222495198

sudeep@sgpgi.ac.in 
Dr Uday Kumar Hosad  Yashoda Hospital, Secunderabad  Consultant Interventional Cardiologist, Department of Cardiology, Yashoda hospital Behind Hari hara Kalabavan,S P Road, Secunderabad Telangana -500003
Hyderabad
TELANGANA 		 9848039671

druday.hosad@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 21  
Name of Committee  Approval Status 
IEC Apex Heart Institute Dr Tejas Patel  Approved 
IEC Apollo Hospital: Dr Sengottuvelu  Approved 
IEC Bangalore Medical College Hospital Dr Divya Prakash  Approved 
IEC Batra Hospital Dr Upendra Kaul  Approved 
IEC BLK Superspeciality Hospital: Dr Subhash Chandra  Approved 
IEC CK Birla Hospital: Dr Dhiman Kahali  Approved 
IEC Deep Hospital: Dr Rakesh Kumar Aggarwal  Approved 
IEC G Kuppuswamy Hospital: Dr Rajpal Abhaichand  Approved 
IEC Maharaja Agrasen Hospital_Dr BB Chanana  Approved 
IEC Medical College Kolkata: Dr Santanu Guha  Approved 
IEC Mysore Medical College: Dr Dinesha Basavanna  Approved 
IEC SGPGI Lucknow: Dr Sudeep Kumar  Approved 
IEC The Madras Medical Mission_Dr Ajit Mullasari  Approved 
IECDrRamManoharLohiaHospital: Dr Mukul Misra  Approved 
IECLTMMCGH Dr Ajay Mahajan  Approved 
Institute EC AIIMS: Dr Ambuj Roy  Approved 
Institutional Ethics Committee Global Hospitals  Approved 
Institutional Ethics Committee Yashoda Academy of Medical Education & Research  Approved 
KEM Hospital Research Centre Ethics Committee  Approved 
KIMS Ethics Committee_Dr Rajendra Kumar Premchand  Approved 
MagnaCareEthics Committee: Dr Manoj Chopda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I502||Systolic (congestive) heart failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ivabradine Immediate Released (IR) Coralan® 5 mg or 7.5 mg Tablets  Dose: Ivabradine Immediate Released (IR) Coralan® 5 mg or 7.5 mg Tablets Route: Oral Frequency: BD Total Duration of Therapy: 03 months Manufactured by: Les Laboratories Servier Industries, France. Imported and Marketed in India by: Serdia® Pharmaceuticals (India) Pvt. Ltd., Serdia House, off Dr. S. S. Rao Road, Parel, Mumbai - 400012. 
Intervention  Ivabradine Prolonged Released (PR) 10 mg or 15 mg Tablets  Dose: Ivabradine Prolonged Released (PR) 10 mg or 15 mg Tablet Route: Oral Frequency: OD Total Duration of Therapy: 03 Months Manufactured by: Abbott Healthcare Pvt. Ltd., India. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Male and female between 18 to 70 years (both inclusive)
2. Currently receiving stable dose of Ivabradine IR 5 mg /7.5 mg BID since ≥ 1 month for stable chronic HF with systolic dysfunction
3. Concurrently receiving standard care for stable CHF (as per recommendation 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic HF)8
4. Documented stable chronic CHF of NYHA Class II to III ≥ 6 weeks at the time of screening
5. Sinus rhythm with clinically stable HR>50 bpm (both inclusive) as assessed automatically by a standard 12-lead ECG
6. Documented LVEF ≤40 % at screening
7. No physical limitation to ingest and retain oral medication
8. Willingness to participate in the study and provide written informed consent
 
 
ExclusionCriteria 
Details  1. History of recent MI, coronary revascularization, stroke, or transient ischemic attack ≤ 3 months), or with a transplanted heart, implanted pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy
2. Scheduled for coronary revascularization, or likely to require surgery for valvular disease during the study period
3. Permanent atrial fibrillation or flutter or any other cardiac arrhythmias which may interfere with function of sinoatrial node
4. Sick sinus syndrome, sinoatrial block, congenital long QT or treated with QT prolonging medications, 2nd degree and complete atrioventricular block
5. Stroke or transient cerebral ischemia within previous ≤ 3 months prior at screening
6. Unstable or acute HF, unstable angina
7. Severe or uncontrolled hypertension (systolic BP [SBP] ≥ 190 mmHg or diastolic BP [DBP] ≥ 110 mmHg) uncontrolled hypotension (SBP ≤ 90 mmHg or DBP ≤ 50 mmHg)
8. History of frequent hypoglycemia within ≤3 months at screening
9. Hospitalization for worsening HF (NYHA class II or higher) ≤ 3 months at screening
10. Any cardiac condition which does not justify the inclusion of the patient in the study as per investigator discretion (e.g. severe primary valvular disease, active myocarditis, congenital heart disease, peripartum cardiomyopathy, etc.)
11. Patient having the following laboratory results at screening:
a. Hemoglobin (Hb) men <11 g/dL, women <10 g/dL
b. ALT/AST levels ≥ 3 х ULN
c. eGFR<15 mL/min
12. Women who are, pregnant, nursing, or planning to become pregnant or who are of childbearing potential not willing to implement appropriate contraceptive measures or who are considering to stop appropriate use of contraception during the study period
13. Contraindication to Ivabradine or its excipients; or Ivabradine not recommended or known to be not effective, or requirement for a not recommended concomitant treatment (as per ProcoralanIvabradine prescribing information and SPC of Procoralan®)
14. History of psychiatric disorders which may interfere with patient’s ability to understand or complete requirements of the study
15. Any other illness or conditions that does not justify patient’s participation in the study as judged by the investigator (E.g. Alcohol abuse, chronic illness like memory loss, Alzheimer’s etc)
16. Is currently participating in any other clinical trial or has participated in any other clinical trial 3 months prior to screening
17. Not willing to comply with all aspects of the protocol
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To compare change in resting HR from baseline to end of 3 months between Ivabradine PR and Ivabradine IR tablets as assessed by taking 3 consecutive ECGs within 30 minutes by automated standard 12lead ECG  Baseline to end of 03 month 
 
Secondary Outcome  
Outcome  TimePoints 
Treatment emergent adverse events (TEAEs) during the study (including nature, severity, and frequency  03 Month 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
Final Enrollment numbers achieved (Total)= "180"
Final Enrollment numbers achieved (India)="180" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   04/05/2018 
Date of Study Completion (India) 03/04/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

This is a prospective, randomized, double-blind, double dummy, multicenter, comparative Phase III clinical trial to evaluate the efficacy and safety of Ivabradine PR tablets versus Ivabradine IR tablets in patients with stable chronic HF with systolic dysfunction.

In addition to above mentioned primary and secondary endpoints below mentioned exploratory endpoints are assessed during study.

·      Incidence for hospitalizations for worsening HF, other CV reasons CV mortality, or all-cause mortality from baseline to end of 3 months during the trial

·      To compare the change in HR (measured by automated 12-lead ECG) versus HR measured by 24-hour Holter ECG (24-hour, awake, and sleep)


 
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