Novel device shows promise in treating drug-resistant hypertension

4 June 2025

High blood pressure (hypertension) remains a significant health challenge globally, affecting over 1.5 billion individuals worldwide. Despite the availability of antihypertensive drugs, a substantial portion of hypertensive patients fail to achieve optimal blood pressure levels, particularly those classified as drug-resistant hypertensive patients. In response to this unmet clinical need, CVCTU is leading SCRATCH-HTN, a groundbreaking study that introduces a novel approach to managing hypertension, potentially revolutionizing treatment for those who have not responded to traditional therapies.

SCRATCH-HTN focuses on a small battery-operated medical device designed to stimulate nerves that control blood pressure. Unlike invasive methods such as renal denervation, where nerves are reduced using catheters, this approach involves participants self-administering stimulation to the nerves responsible for regulating blood pressure. Previous observational studies have shown promising results, indicating that this non-invasive method may effectively reduce blood pressure by restoring the balance between stimulatory and calming nerves.

SCRATCH-HTN aims to recruit 63 randomly assigned participants to receive an active or inactive device, with two in three participants receiving an active one. Importantly, we know from previous research that those who receive an inactive device also benefit when participating in the study—something equivalent to the placebo benefits. This study is designed to be blinded, ensuring that neither participants nor the clinical team know who receives the active device, thereby minimizing bias in the results.

In addition to assessing the device's efficacy in lowering blood pressure, a sub-study will delve deeper into understanding the autonomic nervous system's imbalance in hypertensive patients. This comprehensive approach aims to provide valuable insights into the underlying mechanisms contributing to hypertension, potentially paving the way for more targeted and effective treatments in the future.

Hypertension represents a significant public health burden, contributing to cardiovascular morbidity and mortality worldwide. In the UK alone, over 15 million individuals aged 45-75 are affected by hypertension, with associated healthcare costs exceeding £3.4 billion annually. Despite the availability of antihypertensive drugs, a substantial proportion of patients fail to achieve recommended blood pressure levels, leading to increased risks of cardiovascular events such as heart attacks and strokes.

Current interventions for drug-resistant hypertension, such as catheter-based renal denervation, are invasive, costly, and may require repeat procedures. While effective, these treatments are not accessible to all patients and may pose logistical challenges. In contrast, the novel device being evaluated in this study offers a non-invasive and potentially more accessible alternative, providing hope for individuals who have not responded to traditional therapies.

The approach of targeting the autonomic nervous system represents a promising avenue for treating hypertension. By restoring the delicate balance between sympathetic (stimulatory) and parasympathetic (calming) nervous system activity, this innovative therapy aims to address the root cause of hypertension, offering a more holistic approach to blood pressure management.

The main objective of SCRATCH-HTN is to determine whether treatment with the device can reduce daytime systolic blood pressure more than inactive device (sham) therapy. Secondary objectives include assessing changes in diastolic blood pressure, 24-hour blood pressure variability, and adherence to medications, among others.

In addition to its potential to lower blood pressure, the device may also have broader implications for cardiovascular health, including improvements in quality of life, sleep, and cardiac function. Exploratory objectives aim to evaluate changes in left ventricular function, cognitive function, and baroreflex function, providing valuable insights into the device's multifaceted impact on cardiovascular health.

Overall, the novel device offers a promising solution for individuals with drug-resistant hypertension, addressing an urgent unmet clinical need. This non-invasive therapy can significantly improve outcomes for hypertensive patients, reducing the burden of cardiovascular disease and enhancing overall quality of life. Further research and clinical trials will be crucial in validating the effectiveness and safety of this innovative approach, ultimately bringing hope to millions of individuals worldwide battling with hypertension.