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CTRI Number  CTRI/2017/09/009734 [Registered on: 12/09/2017] 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 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 preserved Ejection Fraction (HFpEF). 
Trial Acronym  None 
Secondary IDs if Any  
Secondary ID  Identifier 
1245.110 Protocol Version 01 dated 09 Nov 16  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, Department of Cardiology, Sector-38, Gurgaon 122001, Haryana, India

Gurgaon
HARYANA
122001
India 
Phone  9560398900  
Fax  0124-4855420  
Email  vk.chopra@medanta.org  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Suneela Thatte 
Designation  Vice president: Global Operations- Asia 
Affiliation  IQVIA RDS (I) Private Limited 
Address  IQVIA RDS (I) PVT. LTD., Mumbai Natraj by Rustomjee 6th Floor, 194 MV Road, Near Western Express Highway Metro Station Andheri East

Mumbai (Suburban)
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- Asia 
Affiliation  IQVIA RDS (I) Private Limited 
Address  IQVIA RDS (I) PVT. LTD., Mumbai Natraj by Rustomjee 6th Floor, 194 MV Road, Near Western Express Highway Metro Station Andheri East

Mumbai (Suburban)
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  
 
Primary Sponsor  
Name  Boehringer Ingelheim Pharma GmbH Co KG 
Address  Binger Strasse 173 55216 Ingelheim am Rhein Germany  
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 
 
Countries of Recruitment     Argentina
Australia
Brazil
Canada
China
Colombia
Czech Republic
Germany
Hungary
India
Italy
Japan
Mexico
Netherlands
Poland
Republic of Korea
Romania
Singapore
South Africa
Spain
United Kingdom
United States of America  
Sites of Study
Modification(s)  
No of Sites = 14  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abraham Oomman  Apollo Hospitals  300132240, 320, Padma Complex, Mount Road, Chennai, Tamilnadu 600035 India
Chennai
TAMIL NADU 		 914428296548
914428294449
drabrahamoomman@gmail.com 
Dr Dhiman Kahali  B M Birla Heart Research Centre  Department : clinical research department Room No : 5th floor 1/1, National Library Avenue, Kolkata-700027. West Bengal, India. Dept: cardiology
Kolkata
WEST BENGAL 		 033-30403023
033-24567006
saujannita.chattopadhyay@birlaheart.org 
Dr Upendra Kaul  Batra Hospital & Medical Research Centre  Tughlakabad Institutional Area, Mehrauli – Badarpur Road, New Delhi – 110062
New Delhi
DELHI 		 911129958747
919811150518
upendra.kaul@batrahospitaldelhi.org 
Dr Vishal Rastogi  Fortis Escorts Heart Institute  Department : Department of cardiology In doctors chambers 2nd Floor, IPD Building , Okhla Road, New Delhi – 110025, India Dept: Interventional cardiology
New Delhi
DELHI 		 9810176317
91-11-26825013
vishal.rastogi@fortishealthcare.com 
Dr Anup Kumar Boro  GNRC Ltd   Department : Cardiology department, Room No : 1st floor GNRC Complex, Dispur, Guwahati-781006 Assam, India Dept: Cardiology
Kamrup
ASSAM 		 9864020000
0361222771
drboro_anup@yahoo.co.in 
Dr Vimal Mehta  Govind Ballabh Pant Institute of Postgraduate Medical Education and Research   Room No-133, 1st Floor, Academic Block, Department of Cardiology, Govind Ballabh Pant Institute of Postgraduate Medical Education and Research J. L. Nehru Marg New Delhi - 110002, India
New Delhi
DELHI 		 9718599105
011-23212554
drvimalmehta@yahoo.co.in 
Dr Bhagwat Ajit Raghunath   Kamalnayan Bajaj Hospital, Marathawada Medical & Research Institute  Department : Research department Room No : 22, Ground floor, 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  Medanta, The Medicity, Gurgaon Sector-38, Gurgaon, Haryana-122001, India
Gurgaon
HARYANA 		 911244141414
911244855420
sanjay.mittal@medanta.org 
Dr Srikanth KV  Narayana Health- Narayana Institute of Cardiac Sciences  epartment of CardiologyNo. 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 : Department of Cardiology Room No : 202 , Kambipura, Mysore Road, Bangalore-560074, Karnataka, India Department : Cardiology
Bangalore
KARNATAKA 		 919739316687
080-28437878
dryogeshkothari@gmail.com 
Dr Nitin Kamalakar Ghaisas  Siddhi Hospital  Clinical Research Room, P-67, Behind ITI Signal, Trimbak Road, MIDC, Satpur, Nashik 422007 Maharashtra, India. Department: Cardiology
Nashik
MAHARASHTRA 		 8275815966
02532352077
nitin.ghaisas@gmail.com 
Dr Ashwani Mehta  Sir Ganga Ram Hospital  Department : Department of Cardiology Room No : 1219 Department : Department of Cardiology Room No : 1219 Department : Department of Cardiology Room No : 1219 Department : Department of Cardiology Room No : 1219 Department of Cardiology, Room No. 1219, SGRH Marg, Rajinder Nagar, New Delhi-110060, India
New Delhi
DELHI 		 9811057384
011-42437230
drashwanimehta@gmail.com 
Dr Ajit Mullasari Sankardas  The Madras Medical Mission  Department : Institute of Cardio Vascular Disease, Division : L Room No : 01 Institute of Cardiovascular disease, 4-a, Dr.J.J.Nagar, Mogappair, Chennai - 600037, Tamilnadu, India Dept: Interventional cardiology
Chennai
TAMIL NADU 		 914426565961
914426565974
icvddoctors@mmm.org.in 
Dr Vinod Vijan   Vijan Cardiac & Critical Care Centre  Research Department , College Road, Nashik, Maharashtra, India. ZIP: 422005 dept: cardiology
Nashik
MAHARASHTRA 		 02532314786
20532315736
vijanhospitalec@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 14  
Name of Committee  Approval Status 
B M Birla Heart Research Centre, Institutional Ethics Committee  Approved 
Ethics Committee Kamalnayan Bajaj Hospital  Approved 
Ethics Committee Sir Ganga Ram Hospital  Approved 
INS trust   Approved 
Institutional Ethics Committee - Clinical Studies  Approved 
Institutional Ethics Committee, The Madras Medical Mission  Approved 
Institutional Ethics Committee, Maulana Azad Medical College and Associated Hospitals  Approved 
Institutional Ethics Committee-Fortis Escorts Heart Institute  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 preserved Ejection Fraction (HFpEF), (1) ICD-10 Condition: I508||Other heart failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Empagliflozin  Dose: 10 mg q.d. Mode of administration: per oral Duration of Treatment: Approximately 20-38 months double-blind treatment until the required number of adjudicated primary events is reached with empagliflozin or placebo  
Comparator Agent  Placebo  Dose: q.d Mode of administration: per oral Duration of Treatment: Approximately 20-38 months double-blind treatment until the required number of adjudicated primary events is reached with empagliflozin or placebo  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Male or female patient, age greater than or equal to 18 years at screening. For Japan only: Age Greater than or equal to 20 years at screening

Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association classification) class II-IV and preserved EF (Ejection Fraction)(LVEF (Left Ventricular Ejection Fraction) > 40 %) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide) > 300 pg/ml for patients without AF, OR Greater than 900 pg/ml for patients with AF, analysed at the Central laboratory at Visit 1

Structural heart disease within 6 months prior to Visit 1, OR documented HHF (Hospitalisation for Heart Failure) within 12 months prior to Visit 1

Stable dose of oral diuretics, if prescribed

Signed and dated written ICF (informed consent form)

Further inclusion criteria apply 
 
ExclusionCriteria 
Details  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

Heart transplant recipient or listed for heart transplant

Acute decompensated HF (Heart Failure)

Systolic blood pressure (SBP) greater than or equal to 180 mmHg at Visit 2.

Symptomatic hypotension and/or a SBP less than 100 mmHg

Indication of liver disease,

Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) less than 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Equation))cr or requiring dialysis

History of ketoacidosis

Treatment with any SGLT (Sodium-glucose co-transporter) -2 inhibitor or combined SGLT-1 and 2 inhibitor

Currently enrolled in another investigational device or drug trial

Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors

Women who are pregnant, nursing, or who plan to become pregnant while in the trial

Further exclusion criteria may apply 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Double Blind Double Dummy 
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 Heart Failure with preserved Ejection Fraction (HFpEF).  up to 38 months 
 
Secondary Outcome  
Outcome  TimePoints 
Occurrence of adjudicated HHF (first and recurrent)  up to 38 months 
eGFR (CKD-EPI)cr slope of change from baseline  up to 38 months 
Time to first occurrence of sustained reduction of ≥40% eGFR(CKD-EPI)cr or sustained eGFR (CKD-EPI)cr 15 mL/min/1.73 m2 for patients with baseline eGFR ≥30 mL/min/1.73 m2 of sustained eGFR (CKD-EPI)cr 10 mL/min/1.73 m2 for patients with baseline eGFR 30 mL/min/1.73 m2  up to 38 months 
Time to first adjudicated HHF   up to 38 months 
Time to adjudicated CV death  up to 38 months 
Time to all-cause mortality- during the entire studyTime to onset of diabetes mellitus (DM) in patients with pre-DM  up to 38 months 
Change from baseline in clinical summary score (HF symptoms and physical limitations domains) of the KCCQ   week 52 
Occurrence of all-cause hospitalization (first and recurrent)  up to 38 months  
 
Target Sample Size   Total Sample Size="4126"
Sample Size from India="100" 
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)   14/09/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  04/04/2017 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="3"
Days="21" 
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 in patients with symptomatic, chronic HF and preserved ejection fraction (LVEF > 40%) under stable treatment of HF symptoms. 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 HFpEF. 
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