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CTRI Number  CTRI/2017/08/009371 [Registered on: 16/08/2017] Trial Registered Prospectively
Last Modified On: 09/03/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Empagliflozin outcome trial in patients with chronic heart failure 
Scientific Title of Study   A phase III randomised, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure with reduced Ejection Fraction (HFrEF). 
Trial Acronym  NAP 
Secondary IDs if Any  
Secondary ID  Identifier 
1245.121 Protocol Version 01 dated 21 October 2016  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vijay Kumar Chopra 
Designation  Director- Heart Failure Program 
Affiliation  Medanta - The Medicity 
Address  Medanta - The Medicity, Sector-38, Gurgaon 122001, Haryana, India
same as address 1
Gurgaon
HARYANA
122001
India 
Phone  9560398900  
Fax  01244855420  
Email  vk.chopra@medanta.org  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Suneela Thatte 
Designation  Vice President- Global Operations 
Affiliation  IQVIA RDS (I) PVT. LTD., 
Address  IQVIA RDS (I) PVT. LTD., Mumbai Natraj by Rustomjee 6th Floor, 194 MV Road, Near Western Express Highway Metro Station Andheri East, Mumbai 400 069

Mumbai
MAHARASHTRA
400069
India 
Phone  912266774242  
Fax  912266774343  
Email  suneela.thatte@quintiles.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Suneela Thatte 
Designation  Vice President- Global Operations 
Affiliation  IQVIA RDS (I) PVT. LTD. 
Address  IQVIA RDS (I) PVT. LTD. Mumbai Natraj by Rustomjee 6th Floor, 194 MV Road, Near Western Express Highway Metro Station Andheri East, Mumbai 400 069

Mumbai
MAHARASHTRA
400069
India 
Phone  912266774242  
Fax  912266774343  
Email  suneela.thatte@quintiles.com  
 
Source of Monetary or Material Support  
Boehringer Ingelheim Pharma GmbH & Co. KG Binger Strasse 173 55216 Ingelheim am Rhein Germany Tel no: 49 6132 778872  
 
Primary Sponsor  
Name  Boehringer Ingelheim Pharma GmbH Co KG 
Address  Binger Strasse 173 55216 Ingelheim am Rhein Germany Tel no: 49 6132 778872  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Quintiles Research India Private Limited  B 101-106, Shapath IV, Opp Karnavati Club- Sarkhej Ghandi Nagar Road ,Ahmedabad 380051, India  
Quintiles Research India Private Limited  B 101-106, Shapath IV, Opp Karnavati Club- Sarkhej Ghandi Nagar Road ,Ahmedabad 380051, India  
 
Countries of Recruitment     Argentina
Brazil
Canada
China
France
Germany
Italy
Japan
Mexico
Netherlands
Poland
Republic of Korea
United Kingdom
United States of America
Australia
Czech Republic
India
Spain  
Sites of Study
Modification(s)  
No of Sites = 13  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abraham Oomman  Apollo Hospitals  No.21,Greams Lane, Off Greams Road, Chennai 600 006 Tamilnadu, India.
Chennai
TAMIL NADU 		 914428296548
914428294449
drabrahamoomman@gmaiI.Com 
Dr Upendra Kaul  Batra Heart Centre, Batra Hospital & Medical Research Centre  Tughlakabad Institutional Area, Mehrauli – Badarpur Road, New Delhi – 110062
New Delhi
DELHI 		 911129958747
919811150518
upendra.kaul@batrahospitaldelhi.org 
Dr Bhupesh Shah  Dr. Jivraj Mehta Smarak Health Foundation  Bakeri Medical Research Center, Ratubhai Adani Arogyadham, Dr.Jivraj Mehta Marg,Ahmedabad-380007,Gujarat,India Dept: Cardiology
Ahmadabad
GUJARAT 		 0792663984043
07926601411
research@jivrajhealthcare.org 
Dr Vishal Rastogi  Fortis Escorts Heart Institute  Okhla Road, New Delhi – 110025, India Department:Cardiology
New Delhi
DELHI 		 9810176317
91-11-26825013
drvrastogi@yahoo.com 
Dr Vimal Mehta  Govind Ballabh Pant Institute of Postgraduate Medical Education and Research  Room No-133, 1st Floor, Academic Block, Department of Cardiology, New Delhi-110002, India
New Delhi
DELHI 		 9718599105
011-23212554
drvimalmehta@yahoo.co.in 
Dr Bhagwat Ajit Raghunath   Kamalnayan Bajaj Hospital  Kamalnayan Bajaj Hospital, Marathawada Medical & Research Institute, Gut No.43, Satara Parisar, Bajaj Marg, Beed Bypass Road, Aurangabad-431005, Maharashtra, India Department : Interventional Cardiology
Aurangabad
MAHARASHTRA 		 02402377999
02402377770
drajitbhagwat@gmail.com 
Dr Sanjay Mittal  Medanta, The Medicity  Sector-38, Gurgaon, Haryana-122001, India
Gurgaon
HARYANA 		 911244141414
911244855420
sanjay.mittal@medanta.org 
Dr Srikanth KV  Narayana Health- Narayana Institute of Cardiac Sciences  No. 258/A, Bommasandra Industrial Area, Hosur Road, Anekal Taluk, Bangalore- 560099. Department : Cardiology
Bangalore
KARNATAKA 		 9342659468
08027835000
srikanthkv02@gmail.com 
Dr Yogesh Kothari  Rajarajeswari Medical College & Hospital  Rajrajeshwari Heart Centre Bangalore, Department of Cardiology #202, Kambipura, Mysore Road, Bangalore-560074, Karnataka, India Department : of Cardiology
Bangalore
KARNATAKA 		 919739316687
080-28437878
dryogeshkothari@gmail.com 
Dr Nitin Kamalakar Ghaisas  Siddhi Hospital  P-67, Behind ITI Signal, Trimbak Road, MIDC, Satpur, Nashik 422007 Maharashtra, India. Department: Cardiology
Nashik
MAHARASHTRA 		 9823122892
91-0253-2352077
nitin.ghaisas@gmail.com 
Dr Ashwani Mehta  Sir Ganga Ram Hospital  SGRH Marg, Rajinder Nagar, New Delhi-110060, India Department : Cardiology
New Delhi
DELHI 		 9811057384
011-42437230
drashwanimehta@gmail.com 
Dr Ajit Mullasari Sankardas  The Madras Medical Mission  Institute of Cardiovascular disease, 4-a, Dr.J.J.Nagar, Mogappair, Chennai - 600037, Tamilnadu, India
Chennai
TAMIL NADU 		 914426565961
914426565974
icvddoctors@mmm.org.in 
Dr Vinod Vijan   Vijan Cardiac & Critical Care Centre  Dr. Vijan Hospital Marg, College Road, Nashik, Maharashtra, India. ZIP: 422005
Nashik
MAHARASHTRA 		 02532314786
2053-2315736
vijanhospitalec@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 13  
Name of Committee  Approval Status 
Ethics Committee Kamalnayan Bajaj Hospital, Marathawada Medical & Research Institute, Gut No.43, Satara Parisar, Bajaj Marg, Beed Bypass Road, Aurangabad-431005, Maharashtra, India  Approved 
Ethics Committee, Sir Ganga Ram Hospital  Approved 
Institutional Ethics Committee - Clinical Studies  Approved 
Institutional Ethics Committee - Dr. Jivraj Mehta Smarak Health Foundation  Approved 
Institutional Ethics Committee,  Approved 
Institutional Ethics Committee, The Madras Medical Mission  Approved 
Institutional Ethics Committee, Maulana Azad Medical College and Associated Hospitals  Approved 
Medanta Institutional Ethics Committee  Approved 
Narayana Health Medical Ethics Committee  Approved 
Rajarajeswari Medical College & Hospital, Institutional Ethics Committee  Approved 
Scientific Research & Ethics Review Committee  Approved 
Siddhi Hospital Institutional Ethics Committee  Approved 
Vijan Hospital Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Chronic Heart Failure with reduced Ejection Fraction (HFrEF), (1) ICD-10 Condition: I508||Other heart failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparator product: Placebo   Test product: Empagliflozin Dose: 10 mg q.d. Mode of administration: Per oral. Comparator product: Placebo Dose: NA Mode of administration:per oral 
Intervention  Test product: Empagliflozin   Dose: 10 mg q.d. Mode of administration: per oral 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Male or female patient age Greater then or equal to 18 years at screening. For Japan only: Age Greater than or equal to 20 years at screening
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines, unless it is implanted within 3 months prior to Visit 1
Signed and dated written ICF (Informed Consent Form)
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class 2-4 and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) less than equal to 40 percent) and elevated NT-pro BNP (N-terminal of the prohormone brain natriuretic peptide)
-If EF greater then equal to 36 percent to less than equal to 40 percent NT-pro BNP greater then equal to 2500 pg per ml
-If EF greater then equal to 31 percent to less than equal to 35 percent NT-proBNP greater than equal to 1000 pg per ml
-If EF less than equal to 30% NT-proBNP greater than equal to 600 pg per ml
 
 
ExclusionCriteria 
Details  1. Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1 2. Heart transplant recipient, or listed for heart transplant 3. Acute decompensated HF 4. Systolic blood pressure (SBP) greater than equal to 180 mmHg at Visit 2. 5. Symptomatic hypotension and/or a SBP less than 100 mmHg 6. Indication of liver disease 7. Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) less than 20 mL per min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis 8. History of ketoacidosis 9. Treatment with any SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor 10. Currently enrolled in another investigational device or drug study 11. Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors 12. Women who are pregnant, nursing, or who plan to become pregnant while in the trial 13. Further exclusion criteria apply 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
The composite primary endpoint for this trial is the time to first event of adjudicated CV death or adjudicated Hospitalisation for Heart Failure in patients with HFrEF.   38 months 
 
Secondary Outcome  
Outcome  TimePoints 
•Occurrence of adjudicated HHF (first and recurrent)  During entire study 
•eGFR (CKD-EPI) slope of change from baseline   During entire study 
Time to first event of sustained reduction of ≥40% eGFR (CKD-EPI) or
•sustained eGFR (CKD-EPI) 15 mL/min/1.73 m2 for patients with baseline eGFR ≥30 mL/min/1.73 m2  		 During entire study 
• sustained eGFR (CKD-EPI) 10 mL/min/1.73 m2 for patients with baseline eGFR 30 mL/min/1.73 m2   During entire study 
•Time to first adjudicated HHF  During entire study 
•Time to adjudicated CV death   During entire study 
•Time to all-cause mortality  During entire study 
•Time to onset of diabetes mellitus (DM) in patients with pre-DM   week 148 
• Change from baseline in clinical summary score (HF symptoms and physical limitations domains) of the KCCQ  week 52 
•Occurrence of all-cause hospitalisation (first and recurrent)  during entire study 
 
Target Sample Size   Total Sample Size="2850"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   21/08/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/04/2017 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="3"
Days="7" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The objective of this event-driven trial is to demonstrate superiority of empagliflozin 10 mg versus placebo on top of guideline-directed medical therapy in patients with symptomatic, chronic HF and reduced ejection fraction (LVEF ≤ 40%).This randomised, double-blind, multi-national, parallel group trial compares empagliflozin 10 mg once daily to placebo as add-on to standard of care treatment in patients with HFrEF. 
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