Research

TOPSPIN Study 

Treatment Optimisation for blood Pressure with Single-Pill Combinations in India (TOPSPIN) study is a multi-center, single-blind trial tailored to South Asian people comparing three Single-Pill Combinations (SPCs) to transform hypertension care. This is a 2-year study by CCDC and funded by Imperial College London, United Kingdom. The study will have a sample size of 1968 patients in total (656 patients per arm). It is currently at the recruitment stage across 35 investigation sites all over India.

Hypertension is a significant cause of mortality and disability in India, affecting around 30% of the population. Importantly, the rates of controlling hypertension are low, standing at 11% in rural areas and 20% in urban areas. Lowering blood pressure to target levels is crucial for preventing cardiovascular issues in hypertensive patients. Often, achieving this goal requires multiple medications. However, there’s a lack of specific trial data on the most effective combinations of antihypertensive drugs for patients of South Asian origin. Current drug selection guidelines in India are primarily based on international standards, which might not fully apply to Indian patients.

In response to this knowledge gap, the TOPSPIN study was designed to compare the effectiveness of three different SPCs of antihypertensive therapies (Amlodipine/Perindopril, Perindopril/Indapamide, and Amlodipine/Indapamide) on 24-hour ambulatory blood pressure levels in Indian patients. This study aims to provide valuable insights for South Asians, who constitute one-sixth of the global population. 

PROJECT EXECUTION

The TOPSPIN study includes male or female hypertensive patients aged 30-79 years. However, patients with a history or evidence of congestive heart failure, renal impairment, coronary heart disease, cerebrovascular disease, contraindications to the investigational product studied, secondary hypertension, or other significant illnesses that might affect the study’s effectiveness are excluded. Additionally, pregnant women or those of childbearing age not using reliable contraception are not part of the study.

After obtaining informed consent, participants will be randomly assigned to one of the study groups. Each patient will be involved in the study for six months, attending follow-up visits at two, four, and six months.

IMPACT

The results from the TOPSPIN study will offer evidence-based information on selecting medications to treat hypertension in the South Asian population. This information will enable physicians to make informed decisions regarding blood pressure-lowering therapies.

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