Renal Denervation in Hypertensive Women Planning to Become Pregnant

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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 .

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:

• ≥ 18 years and ≤ 40 years

• Free, informed, written consent signed by the participant and the investigating physician (no later than the day of inclusion and before any examination required by the research)

• Not pregnant but planning to be pregnant in the near future (\<2 years)

• Patient using effective contraception, preferably micro-progestational, during the screening phase and the two-month post-procedure follow-up

• Essential hypertension confirmed and documented by a previous complete search

• Hypertension treated by 0-2 antihypertensive treatment(s) in a stable manner for at least 4 weeks and whose clinical BP measured in the sitting position during consultation is ≤ 180/110mmHg at the selection visit (D0),

• Person able to understand and agree to follow all study procedures

• Person who is affiliated or beneficiary of a social security plan

Locations
Other Locations
France
CHU de Bordeaux - Hôpital Saint-André
RECRUITING
Bordeaux
CHU Grenoble-Alpes
RECRUITING
Grenoble
CHRU de LILLE - Hôpital Cardiologique
NOT_YET_RECRUITING
Lille
CHU de Nantes - Hôpital Laennec
RECRUITING
Nantes
APHP - Hôpital Européen Georges-Pompidou
RECRUITING
Paris
CHU de TOULOUSE - Hôpital Rangueil
NOT_YET_RECRUITING
Toulouse
Contact Information
Primary
Philippe GOSSE, MD
philippe.gosse@chu-bordeaux.fr
05 56 79 58 89
Backup
Julie GAUDISSARD
julie.gaudissard@chu-bordeaux.fr
05 57 82 08 01
Time Frame
Start Date: 2023-01-31
Estimated Completion Date: 2028-11-30
Participants
Target number of participants: 80
Treatments
Experimental: Denervation treatment
Sham_comparator: Control
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Bordeaux

This content was sourced from clinicaltrials.gov