Women Hypertensive and Young-Renal Denervation

Recruiting now · Not applicable

Conditions studied: Arterial Hypertension

In brief

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 .

Key facts

Study ID

NCT05563337

Run by

University Hospital, Bordeaux

People needed

80

Starts

2023-01-31

Expected to finish

2028-11-30

Last updated by the study team

2023-08-31

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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
• Essential hypertension confirmed and documented by a previous complete search
• Hypertension treated by 0-2 antihypertensive treatment(s) in a stable manner for at least 4 weeks and whose clinical BP measured in the sitting position during consultation 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 ulcerative colitis
• Brachial circumference > 40 cm
• Any history of a cerebrovascular event (stroke, transient ischemic attack)
• Any history of a serious cardiovascular event (myocardial infarction, acute heart failure requiring hospitalization, coronary artery bypass surgery)
• Proven and confirmed episodes of stable or unstable angina in the 12 months preceding consent
• Proven history of persistent or permanent atrial fibrillation
• Presence of an active implantable medical device (e.g. neuromodulator/spinal modulator, baroreflex stimulator, ...)

You may not qualify if…

• 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,
• 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 insertion of the Paradise Catheter
• Infection within 7 days of the procedure

Where it is running

• CHU de Bordeaux - Hôpital Saint-André — Bordeaux, France (enrolling)
• CHU Grenoble-Alpes — Grenoble, France (enrolling)
• CHU de Nantes - Hôpital Laennec — Nantes, France (enrolling)
• APHP - Hôpital Européen Georges-Pompidou — Paris, France (enrolling)
• CHRU de LILLE - Hôpital Cardiologique — Lille, France
• CHU de TOULOUSE - Hôpital Rangueil — Toulouse, France

Full record on ClinicalTrials.gov

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