Clinical Trial

Women Hypertensive and Young-Renal Denervation

Study acronym: WHY-RDN
Recruiting
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Record status
This record was last updated August 31, 2023 (before its estimated May 18, 2025 completion). Its status may not reflect the trial's current state.
Summary
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 .
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-09-28; most recent amendment 2023-08-28.
Status change: Not Yet Recruiting → Recruiting 2023-03-30
Trial Details
NCT Number NCT05563337
Lead Sponsor University Hospital, Bordeaux
Conditions Arterial Hypertension
Enrollment 80 participants
Start Date 2023-01-31
Primary Completion 2025-05-18 (estimated)
Study Completion 2028-11-30 (estimated)
Updated on ClinicalTrials.gov 2023-08-31