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CTRI Number  CTRI/2019/08/020629 [Registered on: 08/08/2019] Trial Registered Prospectively
Last Modified On: 15/05/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study to assess the Prevalence of Heart Failure in Type 2 Diabetes Patients in India 
Scientific Title of Study   An Observational, Cross sectional Study to assess the Prevalence of Heart Failure in Type 2 Diabetes Patients in India 
Trial Acronym  H F Registry 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr J C Mohan 
Designation  Head of Department of cardiology & Sr. Consultant 
Affiliation  Jaipur Golden Hospital Institutional 
Address  Jaipur Golden Hospital Institutional Area Sector 3 Rohini

New Delhi
DELHI
110085
India 
Phone    
Fax    
Email  a51hauzkhas@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shashikanth Chetty 
Designation  Study Physician 
Affiliation  AstraZeneca Pharma India Ltd 
Address  AstraZeneca Pharma India Ltd Bangalore
Manyatha Tech Park
Bangalore
KARNATAKA
560045
India 
Phone    
Fax    
Email  shashikanth.chetty@astrazeneca.com  
 
Details of Contact Person
Public Query
 
Name  Amit Kumar 
Designation  Project Delivery Lead 
Affiliation  AstraZeneca Pharma India Ltd 
Address  AstraZeneca Pharma India Ltd Bangalore
Manyatha Tech Park
Bangalore
KARNATAKA
560045
India 
Phone    
Fax    
Email  Amit.KumarAK@astrazeneca.com  
 
Source of Monetary or Material Support  
AstraZeneca Pharma India Ltd 
 
Primary Sponsor  
Name  AstraZeneca Pharma India Ltd 
Address  Manyata Tech Park,Bangalore 560045 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 22  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Akshata Desai  Apex Hospital  521 New Jawahar Nagar, Jalandhar, Punjab - 144001
Jalandhar
PUNJAB 
9592965544

akshatadesai1@gmail.com 
Dr Tirthankar Chowdhury  Apollo Gleneagles Hospital  58 Canal Circular Road
Kolkata
WEST BENGAL 
9831322394

trithankarc05@gmail.com 
Dr Paramesh Shamanna  Bangalore Diabetic centre  CMR Road, HRBR Layout, 2nd Block, Kalyan Nagar, Bengaluru, Karnataka- 560043
Bangalore
KARNATAKA 
9845010610

drparamesh2@gmail.com 
Dr Rohit Kapoor  Dr Rohit Kapoor’s Heart Station & Diabetes Clinic  2, Rani Ka Bagh, Near Mata Mandir, Amritsar, Punjab-143001
Amritsar
PUNJAB 
9815961619

rohit_kapoor_rohit@yahoo.co.in 
Dr Kamal Sharma  Dr. Kamal Sharma Cardiology Clinic  A/406, Shivalik Yash, 132 Ft. Ring Road, Opp. Shashtri Nagar BRTS Bus Stand, Naranpura, Ahmedabad – 380013
Ahmadabad
GUJARAT 
9426020154

kamalsharma1975@rediffmail.com 
Dr Faraz Farishta  F S Endocrine & Diabetic Center  Opp-Indo English High School, Santosh Nagar, Hyderabad, Telangana 500059
Hyderabad
TELANGANA 
9885035977

drfarazfarishta@gmail.com 
Dr K P Singh  Fortis Med Centre  SCO-11, Chandigarh 160011, India
Chandigarh
CHANDIGARH 
9815311711

drkp1292@gmail.com 
Dr JPS Sahwney  Heart Clinic  House No. 10, Road No.4, West Extension, Near Bikanerwala, Club Road, Punjabi Bagh, Delhi
New Delhi
DELHI 
9810059773

jpssawhney@yahoo.com 
Dr Aditya Batra  Holy Heart Advance care & Research Center  330, Delhi Bypass Chowk, Maharshi Dayanand University, Vinay Nagar, Rohtak, Haryana 124001
Rohtak
HARYANA 
8685000018

adityabatra80@gmail.com 
Dr Ghanshyam Goyal  ILS Hospital  DD-6, Sector 1, Near City Centre, Salt Lake City, Kolkata, West Bengal 700064
Kolkata
WEST BENGAL 
9830400450

drgsgoyal@hotmail.com 
Dr JC Mohan  Jaipur Golden Hospital  Institutional Area, Sector 3, Rohini, Delhi- 110085
New Delhi
DELHI 
9811061392

jcmohan@vsnl.com 
Dr Palaniappan  Medway hospital  No. 2/26, 1st main road, Kodambakam(near sekar. Emporium), Chennai-600024
Chennai
TAMIL NADU 
9384671293

medwayceo@gmail.com 
Dr Dharmesh Ramakant Bhai Solanki  N M Virani Wockhardt Hospital  Kalawad Road Near St. Marys High School, Rajkot, Gujarat 360007
Rajkot
GUJARAT 
9824212020

cardiac_consultants2005@yahoo.co.in 
Dr Sanjay Ananthakrishna  Oxybliss Cardio and Diabetic Research Centre,  No.5, 5th Cross, MLA Layout, Boopasandra, Sanjay nagar, Bangalore- 560094
Bangalore
KARNATAKA 
9900040509

sanjaybnglr@aol.com 
Dr Pankaj Aneja  Pankaj Aneja Clinic  A1 - 81, pocket 1 sector 8 Rohini, Delhi - 110085
North
DELHI 
9811117266

drpankajaneja@gmail.com 
Dr Rajesh Rajput  Postgraduate Institute of Medical Sciences (PGIMS)  Rohtak, Haryana - 124001
Rohtak
HARYANA 
9996013454

drrajeshrajput@outlook.com 
Dr G M Prasad  Pranav Diabetes center  53/1, Nanda Complex, Ramamurthy Nagar Main Road, Annaiah Reddy Layout, Bangalore - 560043
Bangalore
KARNATAKA 
9731911630

gmprasad@gmail.com 
Dr Sanjay Gupta  S G Diabetes Centre   123 D Block C, Kamla Nagar, Delhi, 110007
New Delhi
DELHI 
9811159078

drsanjaygupta12@gmail.com 
Dr Jasjeet Wasir  Sadhu Waswani Medical Centre  4, 4/27, Sector 4, Shanti Niketan, New Delhi, Delhi 110021
New Delhi
DELHI 
9811300206

drjasjeet@gmail.com 
Dr Purushottam Chatterjee  SNC Medispace  48L B.T. Road. Kolkata - 700050
Kolkata
WEST BENGAL 
9433291024

purushchatt2011@gmail.com 
Dr Dinesh Kumar Garg  The Endo Clinic  756, Geeta bhawan marg, Sardarpura, JODHPUR Rajasthan-342001
Jodhpur
RAJASTHAN 
9414912769

theendoclinic@gmail.com 
Dr Sanjeev Aggarwal  The Heart Centre  353, Rohini Sector 8, Pocket C-8, Delhi - 110085
North
DELHI 
9811083153

aggarwal_sanjeev2004@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 22  
Name of Committee  Approval Status 
Conscience Independent Ethics Committee   Approved 
Conscience Independent Ethics Committee  Approved 
Conscience Independent Ethics Committee  Approved 
Conscience Independent Ethics Committee  Approved 
Conscience Independent Ethics Committee  Approved 
Conscience Independent Ethics Committee  Approved 
Conscience Independent Ethics Committee  Approved 
Conscience Independent Ethics Committee  Approved 
Conscience Independent Ethics Committee  Approved 
Conscience Independent Ethics Committee  Approved 
Conscience Independent Ethics Committee  Approved 
Conscience Independent Ethics Committee  Approved 
Conscience Independent Ethics Committee  Approved 
Conscience Independent Ethics Committee  Approved 
Conscience Independent Ethics Committee  Approved 
Conscience Independent Ethics Committee  Approved 
Conscience Independent Ethics Committee  Approved 
Conscience Independent Ethics Committee  Approved 
Conscience Independent Ethics Committee  Approved 
IEC Apollo Gleneagles Hospital,Kolkata  Approved 
ILS Hospital Ethics Committee  Approved 
Medisys Clinisearch Ethical Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Both men and women aged ≥ 18 years
2. Diagnosed with type 2 diabetes (as per ADA Criteria [Annexure 1])
3. Duration of diabetes for 1 year or more
4. Willing to provide written informed consent
 
 
ExclusionCriteria 
Details  1. Patients with evidence of coronary artery disease – CAD (based on the clinical expertise of the physician)
2. Patients who were previously diagnosed with heart failure
3. Patients with evidence of valvular disease based on clinical judgement of the Principle Investigator (PI).
4. Current treatment with digoxin
5. History or symptoms of peripheral artery disease, chronic obstructive pulmonary disease and arrhythmias
6. Patients diagnosed with stage III/IV Chronic Kidney Disease (CKD)
7. Diabetes other than type 2 diabetes mellitus
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Determine the prevalence of LV dysfunction and HF in type 2 DM patients based on the BNP levels and echocardiography results.   10 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Correlation of LV dysfunction and heart failure with demographics and comorbidities of the patients to assess relation between them.  10 Months 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
Final Enrollment numbers achieved (Total)= "621"
Final Enrollment numbers achieved (India)="621" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/08/2019 
Date of Study Completion (India) 14/10/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This is an Observational, Cross sectional Study to assess the Prevalence of Heart Failure in Type 2 Diabetes Patients in IndiaThis registry would aim at identifying the prevalence of HF in Type 2 diabetic patients. The registry will also determine whether there is any association between heart failure and T2DM.

 
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