Why the study?
Blood pressure control remains suboptimal despite antihypertensive drugs, prompting the need to examine the long-term safety and effectiveness of ultrasound renal denervation with the Paradise System in routine clinical practice.
Does ultrasound renal denervation reduce blood pressure and maintain safety in a real-world population of patients with hypertension?
Does ultrasound renal denervation reduce blood pressure and maintain safety in a real-world population of patients with hypertension?
The GPS registry is designed to evaluate the real-world long-term safety and effectiveness of ultrasound renal denervation using the Paradise System in up to 3000 patients with hypertension.
uRDN was associated with substantial real-world BP reduction; leaves open need for randomized confirmation before practice change.
BACKGROUND: Hypertension is a major public health issue due to its association with cardiovascular disease risk. Despite the availability of effective antihypertensive drugs, rates of blood pressure (BP) control remain suboptimal. Renal denervation (RDN) has emerged as an effective non-pharmacological, device-based treatment option for patients with hypertension. The multicenter, single-arm, observational Global Paradise™ System (GPS) registry has been designed to examine the long-term safety and effectiveness of ultrasound RDN (uRDN) with the Paradise System in a large population of patients with hypertension. METHODS: The study aims to enroll up to 3000 patients undergoing uRDN in routine clinical practice. Patients will be recruited over a 4-year period and followed for 5 years (at 3, 6, and 12 months after the uRDN procedure and annually thereafter). Standardized home BP measurements will be taken every 3 months with automatic upload to the cloud. Office and ambulatory BP and adverse events will be collected as per routine clinical practice. Quality-of-Life questionnaires will be used to capture patient-reported outcomes. CONCLUSIONS: This observational registry will provide real-world information on the safety and effectiveness of uRDN in a large population of patients treated during routine clinical practice, and also allow for a better understanding of responses in prespecified subgroups. The focus on home BP in this registry is expected to improve completeness of long-term follow-up and provide unique insights into BP over time.
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Mahfoud et al. (2023) studied this question.
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