A study to understand the risk of heart failure in type 2 diabetes patients in India
Scientific Title of Study
A study to determine the burden of chronic kidney disease (CKD) and risk of heart failure (HF) in subjects with type 2 diabetes mellitus (T2DM) in India (AURA-CH study)
Trial Acronym
AURA-CH
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Chintan Khandhedia
Designation
Team Lead- Clinical Research | RWE
Affiliation
Sun Pharma Laboratories Limited
Address
Sun Pharma Laboratories Limited, Plot No. 201, B-1, Western Express Highway, Goregaon (E)
Mumbai MAHARASHTRA 400063 India
Phone
02243244324
Fax
Email
Chintan.Khandhedia@sunpharma.com
Details of Contact Person Scientific Query
Name
Dr Neeraj Markandeywar
Designation
General Manager- Medical Affairs and Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun Pharma Laboratories Limited, Plot No. 201, B-1, Western Express Highway, Goregaon (E)
Mumbai MAHARASHTRA 400063 India
Phone
9022797378
Fax
Email
Neeraj.Markandeywar@sunpharma.com
Details of Contact Person Public Query
Name
Ms Colette Pinto
Designation
Manager- Clinical Research | RWE
Affiliation
Sun Pharma Laboratories Limited
Address
Sun Pharma Laboratories Limited, Plot No. 201, B-1, Western Express Highway, Goregaon (E)
Mumbai MAHARASHTRA 400063 India
Phone
02243244324
Fax
Email
Colette.Pinto@sunpharma.com
Source of Monetary or Material Support
NIL
Primary Sponsor
Name
Sun Pharma Laboratories Limited
Address
Sun House, Plot No. 201 B-1,
Western Express Highway,
Goregaon (E), Mumbai-400063
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 40
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Ravi Muppidi
AED HOSPITAL
Room No. 102, Department of Endocrinology, Road No: 1, KPHB, Hyderabad-500072
Hyderabad TELANGANA
9885554414
ravimuppidi@gmail.com
Dr Prem Narayanan
Ahalia Diabetic Hospital
Room No. 21, Department of Endocrinology, Kozhipara, Palakkad - 678557
Palakkad KERALA
9037769812
prm_narayanan@yahoo.co.in
Dr Preyander Thakur
AIIMS Bilaspur
Room No. 28, Department of Endocrinology, AIIMS BILASPUR, Changar Palasiyan, Noa, Himachal Pradesh 174001
Bilaspur HIMACHAL PRADESH
9418008966
preyander.thakur@gmail.com
DR MOHAJIT ARNEJA
ARNEJA HEART AND MULTI-SPECIALITY HOSPITAL
Room no. 004, Department of Endocrinology, Plot No 123, behind Somalwar High School, Rajmachi, Ramdaspeth, Nagpur, Maharashtra 440010
Nagpur MAHARASHTRA
99234 04261
arnejamohajit@gmail.com
Dr Srinath A
Bangalore Diagnostic & Multi Speciality Centre
Room No.199, Department of Endocrinology, Shop No.198, 3, 12th Main Rd, above Namma Mtr, 3rd Block, Rajajinagar, Bengaluru, Karnataka 56001
Bangalore KARNATAKA
9916390707
drsrinath1@gmail.com
Dr Vahid S Bharmal
Bhailal Amin Hospital
Room No. 30, Department of Endocrinology, Bhailal Amin Hospital, Gorva, Vadodara - 390003, Gujarat Vadodara GUJARAT
7405368687
vsbharmal@gmail.com
Dr Rama Mohan M V
Diabetes and Endocrine Clinic
Room No. 101, 16/2/219, Department of Endocrinology, Pogathota - 524001
Nellore ANDHRA PRADESH
9490463301
mvramamohan@gmail.com
Dr Ameya Joshi
Dr Ameya Joshi Clinic
Room no 19, Department of Endocrinology, Mandapeshwar Kripa, SV Patel Road, Borivali West, Mumbai, Maharashtra -400091
Mumbai MAHARASHTRA
9820235675
ameyaable@gmail.com
Dr Chandan Misra
Dr Chandan Misra Clinic
Room No. 1, Department of Endocrinology, Kalyani A 7, opposite Jnm emergency gate, Pin - 741235
Kolkata WEST BENGAL
9836983105
drchandan_misra@yahoo.com
Dr Pankaj Manoria
Dr Pankaj Manoria Clinic
Room No. 8, A-1/40, Department of Endocrinology, Kolar Rd, Near Reliance Petrol Pump, Amaltas Phase I, Chuna Bhatti, Bhopal, Madhya Pradesh 462039
Bhopal MADHYA PRADESH
9755530021
pankaj.manoria@gmail.com
Dr Sebabrata Jana
Dr Sebabrata Jana Clinic
Room No 15, Department of Endocrinology, Bargachia hantal road, Bargachia bankul , Howrah- 711410
Haora WEST BENGAL
8017147307
janasebabrata@gmail.com
DR SUNIP BANERJEE
DR SUNIP BANERJEE CLINIC
Room No. 20, Department of Endocrinology,
Southwest of Neelpukur,
Santoshpur, Survey Park-
700075"
Kolkata WEST BENGAL
9831257509
sunipbanerjee@gmail.com
Dr Harish Bajaj
Dr. Harish Bajaj Clinic
Room No. 7, Department of Endocrinology, Aarpee Chambers, Metro Station Marol Naka, Gamdevi, Marol, Andheri East, Mumbai, Maharashtra 400059
Mumbai MAHARASHTRA
8888000026
hhbajaj88@gmail.com
Dr Karthik Balachandran
Dr. Karthik Balachandran Clinic
Room No. 404, Department of Endocrinology, Nr. Mookambika Temple, North Paravoor, Ernakulam - 683513
Ernakulam KERALA
9495935392
karthikbalachandran.dr@gmail.com
Dr Mohan T Shenoy
Dr. Mohan T Shenoy Clinic
Room No. 221, Department of Endocrinology, Sree Gokulam Medical College, Vengaramoodu - 695607
Thiruvananthapuram KERALA
9495944364
drmohanshenoy@gmail.com
Dr Raghu M S
Dr. Raghus Diabetes & Hormone Clinic
Room No. 4, 708, F-59, Department of Endocrinology, Ramanuja Road, opposite to old JSS Hospital old emergency gate, Mysore - 570004 Mysore KARNATAKA
9491823400
dr.msraghu@gmail.com
Dr Umesh Kumar Garg
Dr. Umesh Kumar Garg Clinic
Room No.10, Department of Endocrinology, New Master Plan rd., Lajpat Kunj, Khandari, Agra, Uttar Pradesh - 282002
Agra UTTAR PRADESH
Room No. 26, Department of Endocrinology, White Apts, Sayed Gaon, GH 6, Paschim Vihar, Delhi - 110087
West DELHI
9560597690
drdanendra.endo@gmail.com
Dr Swati Jadhav
Endocan the Hormone Clinic
Room No. 147, Department of Endocrinology, 36th A cross, 7th Main Rd, beside Good shepherd school, 5th Block, Jayanagar, Bengaluru, Karnataka-560076
Bangalore KARNATAKA
94059 04657
drswatijadhav1980@gmail.com
Dr Datta Reddy A
ENDOPLUS CLINIC
Room No. 13, Department of Endocrinology, 2-2-1109/BK/MIG/78/3, Opposite To Naya Tiffins Restaurant 2ND Floor Above Sunglasses Store, Shivam Rd, nearby to Brown Bear Bakery, Hyderabad, Telangana 500044
Hyderabad TELANGANA
9989191927
dattareddyaakiti@gmail.com
Dr Sanjay Gandhi
Gandhi Clinic
Room No. 22, Suruchi Building, Lokmanya Nagar, Navi Peth-Sadashiv Peth Near Viday Shakari Bank And Alka Talkies, opposite Senadatt Police Chowki, Pune, Maharashtra 411030
Pune MAHARASHTRA
9823143210
drgandhisanjay@gmail.com
Dr Shyam Sundar C M
Grapes Clinic
Room No. 2, 1491, first floor, Department of Endocrinology, SV Arcade, Kempegowda Rd, BEML Layout, 5th Stage, Rajarajeshwari Nagar, Bengaluru, Karnataka 560098
Bangalore KARNATAKA
90191 31619
drcmssdm@gmail.com
Dr Bijay Prakash Pandey
Heart Care Clinic
Room No. 20,Dpeartment of Endocrinology, Round Tank Ln, (opposite bSNL office), Howrah-711101 Haora WEST BENGAL
9830020622
pandeybp64@gmail.com
Dr Kanhaiya Agrawal
Hormone and Diabetes Care Clinic
Room No. 001, Department of Endocrinology, Budhvihar Part A, Taramandal, Gorakhpur, UP 273017 Gorakhpur UTTAR PRADESH
9889439830
KanhaiyaAgrawal48@gmail.com
Dr Sanjeet Jaiswal
HORMONE DIABETES HOSPITAL
Room No. C-10, Department of Endocrinology, ASHOKA RATAN, VIDHAN SABHA ROAD, RAIPUR 492001, India, 492007
Raipur CHHATTISGARH
9755137120
jswlsanjeet7@gmail.com
Dr M Senthil Raja
JK Medical Centre
Room No. 104, Department of Endocrinology, Arthanari Gounder Street, Nr Sudhakar ENT hosp., Arthanari Nagar, Swarnapuri, Salem - 636004
Salem TAMIL NADU
9500002860
m.senthilraja2005@gmail.com
Dr Daya Vaswani
Medicover Hospitals
Room No. 3, Department of Endocrinology, Hi-tech city, Madhapur, HYDERABAD, TELANGANA - 500081
Hyderabad TELANGANA
9552455593
dayavaswani@gmail.com
Dr Mahesh Murthy
METRO HOSPITAL
Room No. 6, Department of Endocrinology, SAVALA GA ROAD, SHIVAMOGGA, KARNATAKA - 577205
Shimoga KARNATAKA
8867240693
maheshvaidya26@gmail.com
Dr Ganavi Y P
MS RAMAIH Hospital
Room No. 23, Department of Endocrinology, NEW BEL Road, Mathikere , Bangalore, 560054.
Bangalore KARNATAKA
99646 76972
ganavipattabhi@gmail.com
Dr Pavan S Agrawal
RADIANT MULTISPECIALITY HOSPITAL
Room No. 24, Department of Endocrinology, RUKMANI NAGAR,AMRAVATI, MAHARASHTRA - 440012
Amravati MAHARASHTRA
9225225617
docpavan_1980@yahoo.com
Dr M Rajesh
Rajesh Diabetes & Endocrine Centre
Room No. 11, Department of Endocrinology, Baove BOB, Prakash Nagar, Danavai Peta, Rajamahendravaram, AP - 533103
East Godavari ANDHRA PRADESH
9000952777
drrajeshendo@gmail.com
Dr Shivendra Verma
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Room No. 262, Department of Endocrinology, New PMSSY Rd., Raibareli Rd, Lucknow, Uttar Pradesh - 226014
Lucknow UTTAR PRADESH
8400331063
dr.shivendra@gmail.com
Dr Syed Farooque A
Sehat Hospital
Room No. 8, Department of Endocrinology, Opp Muthoot Finance, Cowl Bazar, Bellary - 583102
Bellary KARNATAKA
9448977392
endodocsfa@gmail.com
Dr Basavaraj GS
Shashi Advanced Health
Room no 203, Department of Endocrinology, 24th Main Rd, 1st Sector, HSR Layout, Bengaluru-560102 Bangalore KARNATAKA
9900190701
basavaraj.gs.dr@narayanahealth.org
Dr Mahesh D M
Shashi Advanced Health
Room No.4,Department of Endocrinology, Ist Main Road, Prashanthnagar, Govindarajanagar, Bangalore,560079. Bangalore KARNATAKA
80564 35894
drmaheshdmendo@gmail.com/
Dr Varun Suryadevara
Spashta Healthcare
Room no. 5, Department of Endocrinology, 1st Floor, Sir M Vishweshwaraiah Road BTM LAYOUT,2nd Block, 6th Stage, Phase 2, Hulimavu,Bengaluru, Karnataka 560076 Bangalore KARNATAKA
82838 33811
varun.suryadevara4@gmail.com
Dr Vishal Poptani
STERLING HOSPITAL
Room No. 10, Department of Endocrinology, 150FT RING ROAD SYNERGY CIRCLE AYODHYA CHOWK OPP GOKUL MATHURA APARTMENT RAJKOT, GUJARAT - 360005"
Rajkot GUJARAT
9825078132
vishpop@hotmail.com
DR PRASHANT JAGTAP
VIVEKA HOSPITAL
Room No. 9, Department of Endocrinology, Plot No. 1A, Naik Layout, Parsodi, Subhash Nagar, Nagpur, Maharashtra 440022
Nagpur MAHARASHTRA
9823078238
pmjagtap@hotmail.com
Dr Vijaya Shekar Reddy D
Yashoda Hospital
Room No. 19, Department of Endocrinology, Hyderabad - 500036
Hyderabad TELANGANA
1. Adults (greater than 18 years) of either gender
2. Subjects with known T2DM (Random plasma glucose greater than or equal to 200 mg per dl or fasting plasma glucose greater than or equal to 126 mg per dl or HbA1c greater than or equal to 6.5 percent or on antidiabetic therapy) for at least 3 months
3. Subjects willing to provide informed consent and comply with study procedures
ExclusionCriteria
Details
1. Subjects with known Diabetes Mellitus (DM) other than T2DM (Type 1 Diabetes Mellitus, maturity onset of Diabetes in young, Latent Autoimmune Diabetes in Adults)
2. Subjects with known T2DM and documented evidence of CKD and HF
3. Subjects with acute renal insufficiency or non-diabetic kidney disease (NDKD) or those on renal replacement therapy
4. Subjects with malignancy or other severe life-threatening conditions affecting study participation
5. Pregnant or lactating women
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Proportion of subjects with CKD, assessed using UACR and or eGFR at baseline and 3 months [UACR greater than or equal to 30 mg per g and or eGFR less than 60 ml per min per 1.73 m2 at baseline and 3 months]
Baseline, 3 months
Secondary Outcome
Outcome
TimePoints
Proportion of subjects at risk of HF, assessed by NT-proBNP levels of greater than 125 pg/mL at baseline
Baseline
Proportion of subjects with CKD stratified based on demographics (age, gender, BMI, duration of T2DM), and comorbidities
Baseline
Proportion of subjects at risk of HF stratified based on demographics (age, gender, BMI, duration of T2DM), and comorbidities
Baseline
Proportion of subjects with CKD risk categories (Low risk, moderately increased risk, high risk and very high risk) using 2024 Kidney Disease: Improving Global Outcomes (KDIGO) staging matrix of CKD at 3 months
3 months
Incidence of major adverse cardiovascular events (MACE) during 6 months [MACE is defined as composite of non-fatal myocardial infarction (MI), non-fatal stroke, cardiovascular death, unstable angina, hospitalization because of HF]
3 months, 6 months
Proportion of subjects with major adverse cardiovascular events (MACE) during the 6 months study period
6 months
Target Sample Size
Total Sample Size="1000" Sample Size from India="1000" 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
N/A
Date of First Enrollment (India)
19/01/2026
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Yet Recruiting
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a multicenter, prospective, longitudinal, observational study designed to assess the burden of chronic kidney disease (CKD) and the risk of heart failure (HF) among adults with type 2 diabetes mellitus (T2DM) in India. Approximately 1000 participants with known T2DM will be enrolled and followed for 6 months.
At baseline and at 3 months, participants will undergo laboratory evaluations including urinary albumin-creatinine ratio (UACR), estimated glomerular filtration rate (eGFR), and NT-proBNP levels to determine CKD burden and HF risk. The study will also evaluate CKD and HF risk distribution based on demographics and comorbidities. Occurrence of major adverse cardiovascular events (MACE) will be recorded up to 6 months. As an observational study, no intervention is administered. Safety assessments include vitals, physical examination, adverse events, and monitoring of MACE throughout the study.