Women Hypertensive and Young-Renal Denervation

Last updated: August 28, 2023
Sponsor: University Hospital, Bordeaux
Overall Status: Active - Recruiting

Phase

N/A

Condition

High Blood Pressure (Hypertension)

Diabetes And Hypertension

High Blood Pressure (Hypertension - Pediatric)

Treatment

Arteriography without renal denervation

Arteriography and renal denervation

Clinical Study ID

NCT05563337
CHUBX 2020/56
2021-A02309-32
  • Ages 18-40
  • Female

Study 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

Inclusion Criteria:

  • ≥ 18 years and ≤ 40 years
  • Free, informed, written consent signed by the participant and the investigatingphysician (no later than the day of inclusion and before any examination required bythe research)
  • Not pregnant but planning to be pregnant in the near future (<2 years)
  • Patient using effective contraception, preferably micro-progestational, during thescreening 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 atleast 4 weeks and whose clinical BP measured in the sitting position duringconsultation 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
  • Hypertension from secondary causes (other than sleep apnea)
  • Documented contraindication or proven severe allergy to iodinated contrast
  • Contraindication to use anticoagulants
  • Renal insufficiency with GFR estimated at < 60ml/min/1.73m²
  • Antihypertensive treatment with more than two active ingredients
  • Type 1 diabetes or uncontrolled type II diabetes (plasma HbA1c level ≥ 9%)
  • History of chronic inflammatory bowel disease such as Crohn's disease or ulcerativecolitis
  • Brachial circumference > 40 cm
  • Any history of a cerebrovascular event (stroke, transient ischemic attack)
  • Any history of a serious cardiovascular event (myocardial infarction, acute heartfailure requiring hospitalization, coronary artery bypass surgery)
  • Proven and confirmed episodes of stable or unstable angina in the 12 months precedingconsent
  • Proven history of persistent or permanent atrial fibrillation
  • Presence of an active implantable medical device (e.g. neuromodulator/spinalmodulator, baroreflex stimulator, ...)
  • Oxygen therapy or permanent ventilation other than CPAP for sleep apnea
  • Primary pulmonary hypertension
  • Limited life expectancy (< 1 year)
  • Unresolved history of drug or alcohol abuse
  • Not have sufficient ability to understand or follow instructions
  • In the investigator's opinion she is unlikely to be willing or able to comply with therequirements of the study protocol or participation in the study will involveconfounding factors in the analysis of the data
  • Participation in another trial of an investigational drug or device (participation ina non-interventional study is tolerated)
  • Pregnant or nursing mother
  • Person unable to give informed consent
  • Person deprived of liberty by judicial or administrative decision
  • Adults under legal protection

Exclusion

Exclusion Criteria:

  • 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 goodquality 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 moreablations,
  • Renal artery anatomy:
  • Main renal artery diameter < 3.0 mm and > 8 mm
  • Main renal artery length < 20 mm
  • A single functioning kidney (low differentiation or small kidney)
  • Kidney tumors presence
  • Renal arterial aneurysm presence
  • Pre-existing renal stent or history of renal artery angioplasty
  • Pre-existing aortic stent or history of aortic aneurysm
  • Prior renal denervation procedure
  • Fibromuscular dysplasia of the renal arteries
  • Presence of renal artery stenosis of any origin ≥ 30%
  • Presence of iliac/femoral artery calcification or stenosis precluding insertionof the Paradise Catheter
  • Infection within 7 days of the procedure

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Arteriography without renal denervation
Phase:
Study Start date:
January 31, 2023
Estimated Completion Date:
November 30, 2028

Study Description

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.

Connect with a study center

  • CHU de Bordeaux - Hôpital Saint-André

    Bordeaux,
    France

    Active - Recruiting

  • CHU Grenoble-Alpes

    Grenoble, 38043 Cedex 9
    France

    Active - Recruiting

  • CHRU de LILLE - Hôpital Cardiologique

    Lille, 59037
    France

    Site Not Available

  • CHU de Nantes - Hôpital Laennec

    Nantes, 44093 cedex 1
    France

    Active - Recruiting

  • APHP - Hôpital Européen Georges-Pompidou

    Paris, 75015
    France

    Active - Recruiting

  • CHU de TOULOUSE - Hôpital Rangueil

    Toulouse, 31059 Cedex 9
    France

    Site Not Available

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