Globally, high systolic blood pressure (SBP) was reported as the leading risk factor for morbidity and mortality. Hypertension is also a leading cause of death and disability in India with a prevalence of 30%. Significant variation was noted in hypertension prevalence among rural (28%) and urban (34%) patients in India. More importantly, hypertension control rates in India are low at 11% and 20% among rural and urban patients respectively.

Reducing BP to target levels is a major priority in preventing cardiovascular events in patients with hypertension, and typically, this requires more than one BP lowering medication in the majority of patients. Single BP lowering drug therapy may help only around 30% of hypertensive patients to achieve the optimal BP control as recommended in recent guidelines. Current guidelines therefore recommend the use of combination therapy as first-line treatment or early in the management of hypertensive patients with co-morbidities that require prompt BP reduction. The latest European guidelines for treating hypertension in adults recommends initiating treatment for most patients with two anti-hypertensive drugs. The combinations recommended in these guidelines are an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) with a calcium channel blocker (CCB) or a thiazide/thiazide-like diuretic for management of high blood pressure in people without other comorbidities such as cardiovascular disease or chronic kidney disease. The latest Indian hypertension guidelines recommend combining low doses of two or more drugs in order to achieve the target BP control. In addition, initial treatment with two anti-hypertensive medications was suggested for those with BP greater than 20/10 mmHg above the goal pressure by international guidelines.

The study was initiated on 29 August 2024. A total of 86 participants were randomized, and 83 completed follow-up, achieving a retention rate of 97 percent. The study was successfully completed with site closeout on 8 August 2024, and the completion report has been submitted.