NCT05563337 Women Hypertensive and Young-Renal Denervation
| NCT ID | NCT05563337 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Bordeaux |
| Condition | Arterial Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-01-31 |
| Primary Completion | 2025-05-18 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief 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 Criteria
Inclusion Criteria: * ≥ 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 Non-Inclusion Criteria: * Males of any age * Females whose age is \<18 years or \>40 * Orthostatic hypotension * Hy