Women Hypertensive and Young-Renal Denervation
ConditionArterial Hypertension
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
This trial does not accept healthy volunteersQualifiers
≥ 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
Design model
Parallel
Treatments tested in this trial
Arteriography and renal denervation
Procedure/SurgeryDiagnostic renal Arteriography - Randomization - Renal denervation
Arteriography without renal denervation
Procedure/SurgeryDiagnostic renal Arteriography - Randomization
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Denervation treatmentExperimental treatment 1 intervention
Group B: ControlSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Normalization of 24h blood pressure
Percentage of patients cured of their hypertension (cure defined as 24h BP\<130/80 mmHg at Day 100 without treatment)
Time frame
at Day 100Secondary outcomes
1
Number of adverse events
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 months2
Number of potential pregnancy complications
Number of potential pregnancy complications between Day 0 and 1 month after end of pregnancy ( 70 months maximum)
Time frame
between Day 0 and 70 months3
Comparison of 24-hour ABPM variations
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 months4
Comparison of Home BP variations
Comparison of Home BP variations between Day 30 and 1 month after end of pregnancy ( 70 months maximum)
Time frame
between Day 30 and 70 monthsSponsors and contacts
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Source ClinicalTrials.gov