Renal denervation for women with hypertension planning pregnancy

Renal Denervation in Hypertensive Women Planning to Become Pregnant

This study tests if a procedure called renal denervation can help women with high blood pressure who are planning to get pregnant manage their condition better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 40 Years
• Sex: Female
• Sponsor: University Hospital, Bordeaux (other)
• Locations: 6 sites (Bordeaux and 5 other locations)
• Trial ID: NCT05563337 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of renal denervation on women with essential hypertension who are planning to become pregnant. Participants will undergo arteriography and be randomized into either a renal denervation group or a control group without the procedure. Blood pressure will be monitored through home measurements and ambulatory blood pressure monitoring (ABPM) before and during pregnancy. The study aims to assess the safety and efficacy of renal denervation in managing hypertension in this specific population.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 to 40 with essential hypertension who are not currently pregnant but plan to conceive within the next two years.

Not a fit: Patients who are male, under 18 or over 40 years old, or those with orthostatic hypotension may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a safer and more effective way to manage hypertension in women planning to become pregnant.

How similar studies have performed: While renal denervation has shown efficacy in resistant hypertension, its application in pregnant women is novel and has not been extensively tested in previous studies.

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

Where this trial is running

Bordeaux and 5 other locations

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

Study contacts

• Study coordinator: Philippe GOSSE, MD

Conditions: Arterial Hypertension, Renal denervation, Pregnancy, Arterial hypertension