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. 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.
Many marginalized groups harbour a historical mistrust of health institutions due in large part to systemic discrimination and events like the gross mishandling of the AIDS crisis. This mistrust manifests in avoidance of healthcare services, leading to delayed disease detection and poorer health outcomes.
Addressing these disparities requires a seismic shift in how health institutions operate. For those working in these institutions, the solution is clear: embrace inclusivity through the following strategies.
Inclusive Study Design: From the inception of research, consider the diverse population that may be impacted. Every decision should be intentional, ensuring the inclusion of all relevant groups and perspectives.
Patient and Public Involvement (PPI): "Nothing about us without us" should guide PPI work. Diverse representation in PPI activities is essential to reduce health research inequalities and foster a collaborative relationship between health institutions and under-served communities.
Loud and Proud Reporting: Researchers should take pride in their inclusive research practices. Transparent reporting on institutional progress toward inclusivity is crucial to build trust with under-represented and under-served groups.
At The Barts CVCTU we are backing up this big talk with tangible actions. All of our studies in development will include demographic data collection as standard, with inclusive response options based on the DAISY guidelines. By standardizing this data collection across studies we are able to give participants a consistent experience, and to compare across our unit where our strengths are, and where we could improve. We will use aggregated data to uncover unintended bias so that we can address inequity and resolve issues of under-representation in our research.
The call for inclusive research practices is loud and clear. Under-served communities deserves equitable representation in health research to dismantle mistrust, improve health outcomes, and foster a future where inclusivity is the norm. It's not just a want; it's a need – and we need that change now.
For more information on the EDI work The Barts CVCTU is doing go to [insert link]
A groundbreaking clinical trial led by Queen Mary University of London, in collaboration with funding from Heart Research UK, has unveiled promising results regarding the use of inorganic nitrate in safeguarding patients against kidney damage during coronary angiographic procedures. The study, published in the European Heart Journal, has revealed that a simple five-day course of once-daily inorganic nitrate significantly reduces the risk of a severe complication following a coronary angiogram, where the dye used can lead to kidney injury.
Contrast-induced nephropathy (CIN), also known as contrast-associated acute kidney injury, is a rare but serious complication that can occur following coronary angiography. This widely employed procedure allows healthcare professionals to assess the blood supply to the heart by injecting a special dye visible on x-rays. However, for certain high-risk patients, including older individuals and those with heart failure or chronic kidney disease, the incidence of CIN can be alarmingly high, reaching up to 55%.
The trial, spearheaded by Professor Amrita Ahluwalia at Queen Mary University of London, aimed to investigate whether ingesting inorganic nitrate could counteract the loss of nitric oxide in the body, a key mechanism underlying CIN. Nitric oxide plays a crucial role in protecting against oxidative stress, which is heightened during angiographic procedures.
Involving 640 patients undergoing angiography for non-ST-elevation Acute Coronary Syndrome at Barts Health NHS Trust, the trial administered once daily inorganic nitrate capsules (potassium nitrate) to 319 participants, while 321 received a placebo capsule (potassium chloride). The results were striking: patients receiving inorganic nitrate treatment exhibited significantly reduced rates of CIN (9.1% vs. 30.5% in the placebo group), along with lower rates of procedural myocardial infarction (2.7% vs. 12.5%) and improved renal function at three months. Moreover, they experienced reduced major adverse cardiac events at one year (9.1% vs. 18.1%) compared to those who received the placebo treatment.
Professor Amrita Ahluwalia Dean for Research, Faculty of Medicine and Dentistry at Queen Mary remarked on the significance of these findings, “The current gold-standard treatment for blocked coronary arteries is inserting a stent. To do this the cardiologist needs to be able to see where the artery is blocked and that is why it is necessary to use a dye to allow the artery to be clearly seen on the angiogram. This trial suggests that a simple 5-day regime of low-cost inorganic nitrate capsule eliminates the risk of what were, up till now, unavoidable damaging effects. We hope to confirm these findings in a large multi-centre trial in the near future, but the results of Nitrate-CIN give us hope.”
Kate Bratt-Farrar, Chief Executive at Heart Research UK, expressed delight in funding this transformative research, emphasizing its potential to enhance coronary angiogram protocols and reduce the risk of serious complications for patients.
The significance of this breakthrough cannot be overstated, especially considering that approximately 250,000 coronary angiograms are performed annually in the UK alone, with CIN accounting for a third of all hospital-acquired acute kidney injuries. With an associated mortality rate of 20.2% for those experiencing CIN, the implications of this research extend far beyond the confines of the laboratory.
The study holds the promise of revolutionizing current medical practices, potentially saving countless lives and improving patient outcomes across the UK and beyond.
Read the paper here: https://academic.oup.com/eurheartj/article-lookup/doi/10.1093/eurheartj/ehae100