NCT05563337: WHY-RDN

Women Hypertensive and Young-Renal Denervation

Recruiting now NA Last updated 31 August 2023

What this trial tests

NA trial testing Arteriography and renal denervation in Arterial Hypertension in 80 participants. Currently enrolling.

Timeline

31 January 2023

Primary endpoint
18 May 2025

30 November 2028

Quick facts

Lead sponsor	University Hospital, Bordeaux
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	80
Start date	31 January 2023
Primary completion	18 May 2025
Estimated completion	30 November 2028
Sites	6 locations across France

Drugs / interventions tested

• Arteriography and renal denervation
• Arteriography without renal denervation

Conditions studied

• Arterial Hypertension — all drugs for Arterial Hypertension →

Sponsor

University Hospital, Bordeaux

Who can join

Adults 18 to 40, female only, with Arterial Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Renal denervation is a new method to lower blood pressure (BP) in hypertensive patients by reducing the impact of sympathetic nervous system. Its efficacy has been demonstrated in resistant hypertension and in lowering BP in essential hypertension as compared to a sham procedure in untreated hypertensive patients. This procedure is safe without any serious adverse events. However its effects during pregnancy are unknown.

Normal pregnancy is associated with an increase of sympathetic activity at rest and upon cardiovascular reflexes stimulation which returns to baseline after delivery. These changes maintain optimal utero placental blood flow. But excessive stimulation of sympathetic activity may play a role in preeclampsia. Drugs that may affect the sympathetic nervous system are considered as safe in pregnant women.

So there are reasonable evidence that renal denervation performed before pregnancy should not have deleterious effects for the fetus. The efficiency of renal denervation being greater in young patient and in women, a greater proportion of BP normalization can be expected in this population of young women .

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Gosse P, Sentilhes L, Boulestreau R, Doublet J, et al · · 2023 · cited 1× · PMID 37775290 · DOI 10.1136/bmjopen-2022-071164