Women Hypertensive and Young-Renal Denervation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorUniversity Hospital, Bordeaux

About this trial

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

Qualifiers

≥ 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

Disqualifiers

BP ≤ 135/85 mmHg and ≥ 160/100 mmHg (ABPM) after 4 weeks washout/run-in period.

Renal arterial anatomy not compatible with renal denervation confirmed by a good quality renal artery angioscan performed within one year prior to consent.

Patient without at least one artery on each side that can be treated with 2 or more ablations,

Main renal artery diameter < 3.0 mm and > 8 mm

Trial design

Treatments tested in this trial

  • Arteriography and renal denervation
  • Arteriography without renal denervation

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators