Actively Recruiting
Women Hypertensive and Young-Renal Denervation
Led by University Hospital, Bordeaux · Updated on 2023-08-31
80
Participants Needed
6
Research Sites
304 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 .
CONDITIONS
Official Title
Women Hypertensive and Young-Renal Denervation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 40 years
- Signed free, informed consent before any study examinations
- Not pregnant but planning to become pregnant within 2 years
- Using effective contraception, preferably micro-progestational, during screening and two months after procedure
- Essential hypertension confirmed and documented
- Stable hypertension treated with 0 to 2 antihypertensive drugs for at least 4 weeks
- Clinical blood pressure at selection visit is 180/110 mmHg or lower
- Able to understand and agree to follow study procedures
- Affiliated with or beneficiary of a social security plan
You will not qualify if you...
- Male of any age
- Female younger than 18 or older than 40 years
- Orthostatic hypotension
- Secondary hypertension causes (excluding sleep apnea)
- Severe allergy or contraindication to iodinated contrast
- Contraindication to anticoagulants
- Renal insufficiency with GFR below 60 ml/min/1.73m²
- More than two active antihypertensive medications
- Type 1 diabetes or uncontrolled type 2 diabetes (HbA1c 9% or higher)
- Chronic inflammatory bowel disease like Crohn's or ulcerative colitis
- Brachial circumference over 40 cm
- History of stroke or transient ischemic attack
- History of serious cardiovascular events requiring hospitalization or surgery
- Stable or unstable angina episodes in past 12 months
- Persistent or permanent atrial fibrillation
- Presence of active implantable medical devices
- Oxygen therapy or permanent ventilation other than CPAP for sleep apnea
- Primary pulmonary hypertension
- Life expectancy under 1 year
- Unresolved drug or alcohol abuse
- Insufficient ability to understand or comply with instructions
- Investigator's judgment of non-compliance or confounding factors
- Participation in another investigational drug or device trial
- Pregnant or nursing
- Unable to give informed consent
- Deprived of liberty by judicial or administrative decision
- Adults under legal protection
- Blood pressure outside 135/85 to 160/100 mmHg range after 4-week washout
- Unsuitable renal artery anatomy for denervation
- Fewer than one treatable artery on each side
- Main renal artery diameter under 3.0 mm or over 8 mm
- Main renal artery length under 20 mm
- Single functioning kidney or small kidney
- Kidney tumors or renal arterial aneurysm
- Previous renal artery stent or angioplasty
- Previous aortic stent or aortic aneurysm
- Prior renal denervation procedure
- Fibromuscular dysplasia of renal arteries
- Renal artery stenosis 30% or greater
- Iliac/femoral artery calcification or stenosis preventing catheter insertion
- Infection within 7 days before procedure
AI-Screening
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Trial Site Locations
Total: 6 locations
1
CHU de Bordeaux - Hôpital Saint-André
Bordeaux, France
Actively Recruiting
2
CHU Grenoble-Alpes
Grenoble, France, 38043 Cedex 9
Actively Recruiting
3
CHRU de LILLE - Hôpital Cardiologique
Lille, France, 59037
Not Yet Recruiting
4
CHU de Nantes - Hôpital Laennec
Nantes, France, 44093 cedex 1
Actively Recruiting
5
APHP - Hôpital Européen Georges-Pompidou
Paris, France, 75015
Actively Recruiting
6
CHU de TOULOUSE - Hôpital Rangueil
Toulouse, France, 31059 Cedex 9
Not Yet Recruiting
Research Team
P
Philippe GOSSE, MD
CONTACT
J
Julie GAUDISSARD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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