NCT05563337

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 .

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
30mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Jan 2023Nov 2028

First Submitted

Initial submission to the registry

August 24, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

January 31, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2025

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2028

Expected
Last Updated

August 31, 2023

Status Verified

August 1, 2022

Enrollment Period

2.3 years

First QC Date

August 24, 2022

Last Update Submit

August 28, 2023

Conditions

Arterial Hypertension

Keywords

Renal denervationPregnancyArterial hypertension

Outcome Measures

Primary Outcomes (1)

  • Normalization of 24h blood pressure

    Percentage of patients cured of their hypertension (cure defined as 24h BP\<130/80 mmHg at Day 100 without treatment)

    at Day 100

Secondary Outcomes (5)

  • Number of adverse events

    between Day 0 and 70 months

  • Number of potential pregnancy complications

    between Day 0 and 70 months

  • Comparison of 24-hour ABPM variations

    between Day 30 and 70 months

  • Comparison of Home BP variations

    between Day 30 and 70 months

  • Number of antihypertensive treatments used

    at Day 100

Study Arms (2)

Denervation treatment

EXPERIMENTAL
Procedure: Arteriography and renal denervation

Control

SHAM COMPARATOR
Procedure: Arteriography without renal denervation

Interventions

Arteriography and renal denervationPROCEDURE

Diagnostic renal Arteriography - Randomization - Renal denervation

Denervation treatment
Arteriography without renal denervationPROCEDURE

Diagnostic renal Arteriography - Randomization

Control

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ≥ 18 years and ≤ 40 years
  • 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
  • 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
  • +19 more criteria

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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CHU de Bordeaux - Hôpital Saint-André

Bordeaux, France

RECRUITING

CHU Grenoble-Alpes

Grenoble, 38043 Cedex 9, France

RECRUITING

CHRU de LILLE - Hôpital Cardiologique

Lille, 59037, France

NOT YET RECRUITING

CHU de Nantes - Hôpital Laennec

Nantes, 44093 cedex 1, France

RECRUITING

APHP - Hôpital Européen Georges-Pompidou

Paris, 75015, France

RECRUITING

CHU de TOULOUSE - Hôpital Rangueil

Toulouse, 31059 Cedex 9, France

NOT YET RECRUITING

Related Publications (1)

  • Gosse P, Sentilhes L, Boulestreau R, Doublet J, Gaudissard J, Azizi M, Cremer A; WHY-RDN investigators. Endovascular ultrasound renal denervation to lower blood pressure in young hypertensive women planning pregnancy: study protocol for a multicentre randomised, blinded and sham controlled proof of concept study. BMJ Open. 2023 Sep 29;13(9):e071164. doi: 10.1136/bmjopen-2022-071164.

    PMID: 37775290DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Philippe GOSSE, MD

    University Hospital, Bordeaux

    STUDY DIRECTOR

Central Study Contacts

Philippe GOSSE, MD

CONTACT

05 56 79 58 89philippe.gosse@chu-bordeaux.fr

Julie GAUDISSARD

CONTACT

05 57 82 08 01julie.gaudissard@chu-bordeaux.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Physician who will perform the renal arteriography and renal denervation in case of randomization in the "renal denervation group" will be different from the cardiologist who will follow the patient throughout the study in order to keep the double blind
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2022

First Posted

October 3, 2022

Study Start

January 31, 2023

Primary Completion

May 18, 2025

Study Completion (Estimated)

November 30, 2028

Last Updated

August 31, 2023

Record last verified: 2022-08

Locations

FR(6)