The Indian REgistry on Current Patient PrOfiles and TReatment TrenDs in Hypertension (RECORD)
- Conditions
- Essential (primary) hypertension,
- Registration Number
- CTRI/2019/01/017314
- Lead Sponsor
- Glenmark Pharmaceuticals Limited
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 2000
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.
- 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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 24 months 2. Difference in the adherence rate to different antihypertensive agents/regimens, including factors influencing adherence to antihypertensive treatment 24 months 3. Changes in the quality of life before and after various anti-hypertensive treatment regimens 24 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (5)
Apollo Hospital, Chennai
🇮🇳Chennai, TAMIL NADU, India
Dr. Ram Manohar Lohia Institute of Medical Sciences
🇮🇳Lucknow, UTTAR PRADESH, India
King Georges Medical University
🇮🇳Lucknow, UTTAR PRADESH, India
St. Johns Medical College and Hospital
🇮🇳Bangalore, KARNATAKA, India
T. N. Medical College & BYL Nair Ch. Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Apollo Hospital, Chennai🇮🇳Chennai, TAMIL NADU, IndiaDr Abraham OommanPrincipal investigator9841174578drabrahamoomman@gmail.com