Women Hypertensive and Young-Renal Denervation

Launched by UNIVERSITY HOSPITAL, BORDEAUX · Sep 28, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called renal denervation, which aims to lower high blood pressure in young women who have essential hypertension and are planning to become pregnant soon. The procedure works by reducing the effects of the sympathetic nervous system, which can contribute to high blood pressure. Research has shown that this method is effective and safe for many patients, but its effects during pregnancy are still being explored. The trial specifically seeks women aged 18 to 40 who have been diagnosed with high blood pressure and are not currently pregnant but are considering pregnancy within the next two years.

Participants in the trial will undergo the renal denervation procedure and will be monitored for their blood pressure levels and overall health afterward. To join the study, women need to meet certain criteria, such as having documented essential hypertension and being on a stable treatment plan for at least four weeks. It's important for participants to understand the study procedures and agree to follow them. The trial aims to better understand how this treatment can benefit young women with high blood pressure, especially those who may become pregnant in the near future.

Gender

FEMALE

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