Arteriography and renal denervation
ProcedureDiagnostic renal Arteriography - Randomization - Renal denervation
NCT Number: NCT05563337
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 .
Interested in participating?
Request Info18 year–40 year
Female
Interventional
Not applicable
CHU de Bordeaux - Hôpital Saint-André, Bordeaux, France
Investigators will include women with essential hypertension, treated or untreated, who are planning a short term pregnancy (D0). If high blood pressure is confirmed by ABPM after one month without treatment (D30), investigators will proceed to the arteriography during which they will be randomized in the renal denervation group or in the control one.
After the randomization, BP monitoring by Home BP measurement will be performed every month and send to the investigator. Then the patient will benefit from a new ABPM two months after the intervention (D100), and she may stop contraception and may become pregnant. BP will be monitored during pregnancy by home BP and by a new ABPM at the beginning of the 6th month of pregnancy as well as one, one month after delivery. From the D100, the patient will be able to start an antihypertensive treatment at any time depending on HBPM or ABPM.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Non-Inclusion Criteria:
Exclusion criteria
Diagnostic renal Arteriography - Randomization - Renal denervation
Diagnostic renal Arteriography - Randomization
Time frame: at Day 100
Percentage of patients cured of their hypertension (cure defined as 24h BP<130/80 mmHg at Day 100 without treatment)
Time frame: between Day 0 and 70 months
Number of adverse events following denervation compared to the control procedure between Day 0 and 1 month after end of pregnancy ( 70 months maximum)
Time frame: between Day 0 and 70 months
Number of potential pregnancy complications between Day 0 and 1 month after end of pregnancy ( 70 months maximum)
Time frame: between Day 30 and 70 months
Comparison of 24-hour ABPM variations between Day 30 and 1 month after end of pregnancy ( 70 months maximum)
Time frame: between Day 30 and 70 months
Comparison of Home BP variations between Day 30 and 1 month after end of pregnancy ( 70 months maximum)
Time frame: at Day 100
Contact information is provided by the study sponsor or research team.
University Hospital, Bordeaux
Other
Renal Denervation in Hypertensive Women Planning to Become Pregnant
Acronym: WHY-RDN
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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