A multinational clinical approach to assessing the effectiveness of catheter-based ultrasound renal denervation: The RADIANCE-HTN and REQUIRE clinical study designs

Beitrag in einer Fachzeitschrift


Details zur Publikation

Autorinnen und Autoren: Mauri L, Kario K, Basile J, Daemen J, Davies J, Kirtane AJ, Mahfoud F, Schmieder R, Weber M, Nanto S, Azizi M
Zeitschrift: American Heart Journal
Jahr der Veröffentlichung: 2018
Band: 195
Seitenbereich: 115-129
ISSN: 0002-8703
eISSN: 1097-6744


Abstract

Catheter-based renal denervation is a new approach to treat hypertension via modulation of the renal sympathetic nerves. Although nonrandomized and small, open-label randomized studies resulted in significant reductions in office blood pressure 6months after renal denervation with monopolar radiofrequency catheters, the first prospective, randomized, sham-controlled study (Symplicity HTN-3) failed to meet its blood pressure efficacy end point. New clinical trials with new catheters have since been designed to address the limitations of earlier studies. Accordingly, the RADIANCE-HTN and REQUIRE studies are multicenter, blinded, randomized, sham-controlled trials designed to assess the blood pressure-lowering efficacy of the ultrasound-based renal denervation system (Paradise) in patients with established hypertension either on or off antihypertensive medications, is designed to evaluate patients in 2 cohorts-SOLO and TRIO, in the United States and Europe. The SOLO cohort includes patients with essential hypertension, at low cardiovascular risk, and either controlled on 1 to 2 antihypertensive medications or uncontrolled on 0 to 2 antihypertensive medications. Patients undergo a 4-week medication washout period before randomization to renal denervation (treatment) or renal angiogram (sham). The TRIO cohort includes patients with hypertension resistant to at least 3 antihypertensive drugs including a diuretic. Patients will be stabilized on a single-pill, triple-antihypertensive-drug combination for 4weeks before randomization to treatment or sham. Reduction in daytime ambulatory systolic blood pressure (primary end point) will be assessed at 2months in both cohorts. A predefined medication escalation protocol, as needed for blood pressure control, is implemented between 2 and 6months in both cohorts by a study staff member blinded to the randomization process. At 6months, daytime ambulatory blood pressure and antihypertensive treatment score will be assessed. REQUIRE is designed to evaluate patients with resistant hypertension on standard of care medication in Japan and Korea. Reduction in 24-hour ambulatory systolic blood pressure will be assessed at 3months (primary end point). Both studies are enrolling patients, and their results are expected in 2018.


FAU-Autorinnen und Autoren / FAU-Herausgeberinnen und Herausgeber

Schmieder, Roland Prof. Dr.
Professur für Innere Medizin (Nephrologie)


Einrichtungen weiterer Autorinnen und Autoren

Brigham and Women's Hospital (BWH)
Columbia University
Erasmus University Medical Center
Hammersmith Hospital
Jichi Medical University / 自治医科大学
Medical University of South Carolina (MUSC)
Nishinomiya Municipal Central Hospital / 西宮市立中央病院
SUNY Downstate Medical Center
Universitätsklinikum des Saarlandes
University of Paris 5 - René Descartes / Université Paris V René Descartes


Zitierweisen

APA:
Mauri, L., Kario, K., Basile, J., Daemen, J., Davies, J., Kirtane, A.J.,... Azizi, M. (2018). A multinational clinical approach to assessing the effectiveness of catheter-based ultrasound renal denervation: The RADIANCE-HTN and REQUIRE clinical study designs. American Heart Journal, 195, 115-129. https://dx.doi.org/10.1016/j.ahj.2017.09.006

MLA:
Mauri, Laura, et al. "A multinational clinical approach to assessing the effectiveness of catheter-based ultrasound renal denervation: The RADIANCE-HTN and REQUIRE clinical study designs." American Heart Journal 195 (2018): 115-129.

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Zuletzt aktualisiert 2018-09-10 um 02:16