Rationale, study design and methodology of the hypertension registry: a Pan-India, prospective, longitudinal study to assess management and real-world outcomes of high-risk essential hypertension

Background: India contributes significantly towards a large part of the worldwide epidemic of hypertension (HTN) and its associated complications. As, there are limited longitudinal studies available in India to understand its occurrence over time, this Pan-India longitudinal study will aid to assess the real world outcomes of HTN across the country. Methods: This was a prospective, multi-centered, longitudinal, observational study investigating a large COHORT of people with HTN across India over a period of one year. The primary objective of this study was to evaluate blood pressure (BP) control and clinical outcomes in high-risk hypertensive patients distributed over 5 visits (including baseline visit). The secondary objective is to assess the co-morbidities/risk factors in different clinical settings across India. Participants (4,000) with HTN will be included from 200 centres across India and data will be recorded for the use of anti-hypertensives, demographics, socio-economic status, anthropometric measurements, family history, personal history, risk factors, co-morbid conditions and physician treatment preferences. Overall, clinical practice patterns were assessed for their relationship with clinical outcomes. Conclusions: This study is expected to reveal the trends in complications associated with HTN, treatment strategies used by physicians, and correlation among treatment, control and complications of HTN within the Indian context. The outcome of this study will help to identify the burden of HTN, along with pin-pointing the emergence of early-onset complications and dose titration patterns. This will eventually help to develop person-centred care and facilitate public health agencies to invest appropriate resources in the management of high-risk HTN across India. Trial registration: This is a real world evidence generation study which has been registered on Clinical Trials Registry-India (CTRI). The registration number for the same is CTRI/2020/07/026524.