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CTRI Number  CTRI/2019/01/017314 [Registered on: 31/01/2019] Trial Registered Prospectively
Last Modified On: 06/08/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   The Indian REgistry on Current Patient PrOfiles and TReatment TrenDs in Hypertension (RECORD) 
Scientific Title of Study   A Prospective Cohort, Multicentric, Non-interventional, Observational, Real-World Study to Evaluate Current Clinical Practices and Quality of Life in Indian Essential Hypertensive Patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Girish Rajadhyaksha  
Designation  Professor 
Affiliation  T. N. Medical College & BYL Nair Ch. Hospital 
Address  Department of General medicine, 104 College Building, B. Y. L. Nair Charitable Hospital

Mumbai
MAHARASHTRA
400008
India 
Phone  9821695349  
Fax    
Email  girishraj63@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sachin Suryawanshi 
Designation  Deputy General Manager - MEDICAL SERVICESHOIF 
Affiliation  Glenmark Pharmaceuticals Limited 
Address  Glenmark Corporate Enclave, BD Sawant Marg, Andheri East

Mumbai
MAHARASHTRA
400099
India 
Phone    
Fax    
Email  Sachin.Suryawanshi@glenmarkpharma.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sachin Suryawanshi 
Designation  Deputy General Manager - MEDICAL SERVICESHOIF 
Affiliation  Glenmark Pharmaceuticals Limited 
Address  Glenmark Corporate Enclave, BD Sawant Marg, Andheri East

Osmanabad
MAHARASHTRA
400099
India 
Phone    
Fax    
Email  Sachin.Suryawanshi@glenmarkpharma.com  
 
Source of Monetary or Material Support  
Glenmark Pharmaceuticals Limited 
 
Primary Sponsor  
Name  Glenmark Pharmaceuticals Limited 
Address  Glenmark Corporate Enclave, BD Sawant Marg, Andheri East Mumbai 400099  
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 = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abraham Oomman   Apollo Hospital, Chennai  No: 21, Greams Lane, Off Greams Road
Chennai
TAMIL NADU 
9841174578

drabrahamoomman@gmail.com 
Dr Amresh Kumar Singh  Dr. Ram Manohar Lohia Institute of Medical Sciences  Department of Cardiology Vibhuti khand, Gomti Nagar, Lucknow – 226010
Lucknow
UTTAR PRADESH 
9496603304

dramresh.singh5@gmail.com 
Dr Himanshu Dandu  King Georges Medical University  Erstwhile Chhatrapati Shahuji Maharaj Medical University), Chowk
Lucknow
UTTAR PRADESH 
9839266822

dr.himanshureddy@gmail.com 
Dr Srilakshmi MA  St. Johns Medical College and Hospital  Sarjapur Main Road,Bengaluru, Karnataka 560034
Bangalore
KARNATAKA 
08025633087

cardioresearch@gmail.com 
Dr Girish Rajadhyaksha  T. N. Medical College & BYL Nair Ch. Hospital   Department of General medicine 104 College Building, B. Y. L. Nair Charitable Hospital, Mumbai MAHARASHTRA-400008 India
Mumbai
MAHARASHTRA 
9821695349

girishraj63@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Dr Ram Manohar Lohia Institute of Medical Sciences  Approved 
Ethics Committee of King Georges Medical University  Approved 
Institutional Ethics Committee, Clinical Studies, Apollo Hospitals  Approved 
St Johns Medical College, IEC  Approved 
Topiwala National Medical College and BYL Nair CH. Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1-Patients of either sex aged >18 years
2-Patients with a diagnosis of essential hypertension under the criteria established by the American College of Cardiology/American Heart Association (ACC/AHA) 2017 or the European Society of Cardiology (ESC)/European Society of Hypertension (ESH) 2018 hypertension guidelines; and those patients under antihypertensive treatment with the same therapeutic regimen for the past 3 months
3-Patients willing to sign the informed consent form  
 
ExclusionCriteria 
Details  1. Patients with secondary hypertension
2. Pregnant women or nursing mothers
3. Patients with acute illnesses or having a definite psychiatric diagnosis, as well as those patients, who in the opinion of the investigator, are unlikely to fulfill the study requirements
4. Patients currently enrolled in or have not yet completed at least 30 days since ending an investigational product or device study or are receiving investigational agents
5. Patients with other comorbidities that may limit life expectancy to less than one year  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Pattern of pharmacological treatments prescribed by physicians in India to treat patients with newly diagnosed essential hypertension or patients with existing essential hypertension and on the same treatment for the past 3 months
2. Difference in the adherence rate to different antihypertensive agents/regimens, including factors influencing adherence to antihypertensive treatment
3. Changes in the quality of life before and after various anti-hypertensive treatment regimens
 
24 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Percentage of patients with target organ damage at 1 year and 2 years after enrollment
2. Percentage of patients reaching target blood pressure according to the ACC/AHA 2017 or ESC/ESH 2018 criteria (as per the prevailing clinical practices) at follow-up with various antihypertensive treatment regimens
3. Percentage of patients hospitalized during the study period, with reasons for the same 
24 months 
 
Target Sample Size   Total Sample Size="2000"
Sample Size from India="2000" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/02/2019 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
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  
Hypertension is a common noncommunicable disease (NCD) and a silent threat to the overall health of an individual. The disease accounts for approximately 45% of deaths due to heart disease, and 51% of deaths due to stroke, globally, and exerts a substantial burden on healthcare systems worldwide, as well as in emerging economies such as India.  National surveys, meta-analyses, and several studies have highlighted the increasing prevalence and burden of hypertension in India, in both urban and rural settings. This coupled with the lack of disease awareness among the general population further complicates the management of hypertension in India. Advancing age, alcohol and tobacco intake, smoking, obesity, high consumption of dietary fat and salt, and sedentary lifestyle are significant risk factors for hypertension in India. 

Ironically, despite the availability of various tools to diagnose and treat hypertension, a substantial proportion of patients exhibit uncontrolled hypertension in India. The inefficient management of the disease, thus, makes patients prone to a range of serious complications, such as coronary artery disease, myocardial infarction, cardiac failure, renal insufficiency, and eventually death. One of the key factors contributing to uncontrolled hypertension in India is the lack of adherence to the prescribed treatment agent and regimen. Poor adherence to treatment not only has an impact on the effectiveness of the treatment, but it also broadly impacts the patient’s quality of life. Another important unmet need in the management of hypertension in India is a dearth of data concerning the awareness, treatment patterns, control of hypertension, and the impact of treatment on the quality of life of patients.  
 
Therefore, the current real-world registry study aims to evaluate a larger hypertensive population treated in both private- and public-sector healthcare settings in India, to
• Understand current trends in hypertension in India, including clinical perspectives, disease management approaches, and hypertension-control strategies applied 
• Understand the course of patients with primary hypertension, including those with underlying risk factors or comorbid conditions, and to determine prognostic outcomes based on various lines of anti hypertensive drug 
• Evaluate and identify the criteria for hospitalization or up titration of anti hypertensive therapy to a higher dose or for the addition of a new drug from a different class 
• Obtain deeper knowledge of adherence to anti hypertensive drug treatment and to evaluate the quality of life in patients with essential hypertension in India 
• Identify factors affecting adherence to antihypertensive treatment Compare levels of adherence to different drug regimens 
• Understand treatment differences between public and private healthcare settings in India 
 
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