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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
Intervention / Comparator Agent
|
|
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 |