NCT05563337 Women Hypertensive and Young-Renal Denervation
| NCT ID | NCT05563337 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Bordeaux |
| Condition | Arterial Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-01-31 |
| Primary Completion | 2025-05-18 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2023-01-31 with a primary completion date of 2025-05-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria: * ≥ 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, ...) * 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 the requirements of the study protocol or participation in the study will involve confounding factors in the analysis of the data * Participation in another trial of an investigational drug or device (participation in a 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 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 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
Contact & Investigator
Philippe GOSSE, MD
STUDY DIRECTOR
University Hospital, Bordeaux
Frequently Asked Questions
Who can join the NCT05563337 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Arterial Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05563337 currently recruiting?
Yes, NCT05563337 is actively recruiting participants. Contact the research team at philippe.gosse@chu-bordeaux.fr for enrollment information.
Where is the NCT05563337 trial being conducted?
This trial is being conducted at Bordeaux, France, Grenoble, France, Lille, France, Nantes, France and 2 additional locations.
Who is sponsoring the NCT05563337 clinical trial?
NCT05563337 is sponsored by University Hospital, Bordeaux. The principal investigator is Philippe GOSSE, MD at University Hospital, Bordeaux. The trial plans to enroll 80 participants.