Endovascular ultrasound renal denervation to lower blood pressure in young hypertensive women planning pregnancy: study protocol for a multicentre randomised, blinded and sham controlled proof of concept study
| Autor: | Laurence Amar, Hélène Bouvaist, Anne Blanchard, Guillaume Lamirault, Didier Riethmuller, Loïc Sentilhes, Philippe Gosse, Louise Ghesquière, Pascal Delsart, Marc Sapoval, Patrice Guérin, Michel Azizi, Rosa Maria Bruno, Romain Boulestreau, Julien Doublet, Julie Gaudissard, Antoine Cremer, Vassilis Tsatsaris, Claire Mounier Vehier, Guillaume Ledieu, Benjamin Longere, Olivier Ormezzano, Charlotte Casser, Yannick Neuder, Mathieu Rodiere, Béatrice Duly-Bouhanick, Paul Guerby, Hervé Rousseau, Robert Winer |
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| Jazyk: | angličtina |
| Rok vydání: | 2023 |
| Předmět: | |
| Zdroj: | BMJ Open, Vol 13, Iss 9 (2023) |
| Druh dokumentu: | article |
| ISSN: | 2044-6055 76512533 |
| DOI: | 10.1136/bmjopen-2022-071164 |
| Popis: | Introduction A major issue confronting clinicians treating hypertension in pregnancy is the limited number of pharmacological options. Endovascular catheter-based renal denervation (RDN) is a new method to lower blood pressure (BP) in patients with hypertension by reducing the activity of the renal sympathetic nervous system. Drugs that affect this system are safe in pregnant women. So there is reasonable evidence that RDN performed before pregnancy should not have deleterious effects for the fetus. Because the efficacy of RDN may be greater in younger patients and in women, we may expect a larger proportion of BP normalisation in young hypertensive women, but this remains to be proven. Our primary objective is to quantify the proportion of BP normalisation with RDN in this population.Methods and analysis WHY-RDN is a multicentre randomised sham-controlled trial conducted in six French hypertension centres that will include 80 women with essential hypertension treated or untreated, who are planning a pregnancy in the next 2 years and will be randomly assigned to RDN or classic renal arteriography and sham RDN in a ratio of 1:1. The primary outcome is the normalisation of 24-hour BP ( |
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