Last updated: August 28, 2023
Sponsor: University Hospital, Bordeaux
Overall Status: Active - Recruiting
Phase
N/A
Condition
High Blood Pressure (Hypertension)
Diabetes And Hypertension
High Blood Pressure (Hypertension - Pediatric)
Treatment
Arteriography without renal denervation
Arteriography and renal denervation
Clinical Study ID
NCT05563337
CHUBX 2020/56
2021-A02309-32
Ages 18-40 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- ≥ 18 years and ≤ 40 years
- Free, informed, written consent signed by the participant and the investigatingphysician (no later than the day of inclusion and before any examination required bythe research)
- Not pregnant but planning to be pregnant in the near future (<2 years)
- Patient using effective contraception, preferably micro-progestational, during thescreening 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 atleast 4 weeks and whose clinical BP measured in the sitting position duringconsultation 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 ulcerativecolitis
- Brachial circumference > 40 cm
- Any history of a cerebrovascular event (stroke, transient ischemic attack)
- Any history of a serious cardiovascular event (myocardial infarction, acute heartfailure requiring hospitalization, coronary artery bypass surgery)
- Proven and confirmed episodes of stable or unstable angina in the 12 months precedingconsent
- Proven history of persistent or permanent atrial fibrillation
- Presence of an active implantable medical device (e.g. neuromodulator/spinalmodulator, 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 therequirements of the study protocol or participation in the study will involveconfounding factors in the analysis of the data
- Participation in another trial of an investigational drug or device (participation ina 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
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 goodquality 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 moreablations,
- 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 insertionof the Paradise Catheter
- Infection within 7 days of the procedure
Study Design
Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Arteriography without renal denervation
Phase:
Study Start date:
January 31, 2023
Estimated Completion Date:
November 30, 2028
Study Description
Connect with a study center
CHU de Bordeaux - Hôpital Saint-André
Bordeaux,
FranceActive - Recruiting
CHU Grenoble-Alpes
Grenoble, 38043 Cedex 9
FranceActive - Recruiting
CHRU de LILLE - Hôpital Cardiologique
Lille, 59037
FranceSite Not Available
CHU de Nantes - Hôpital Laennec
Nantes, 44093 cedex 1
FranceActive - Recruiting
APHP - Hôpital Européen Georges-Pompidou
Paris, 75015
FranceActive - Recruiting
CHU de TOULOUSE - Hôpital Rangueil
Toulouse, 31059 Cedex 9
FranceSite Not Available
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