search
Back to results

Women Hypertensive and Young-Renal Denervation (WHY-RDN)

Primary Purpose

Arterial Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Arteriography and renal denervation
Arteriography without renal denervation
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Arterial Hypertension focused on measuring Renal denervation, Pregnancy, Arterial hypertension

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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
  • Clinical BP measured in sitting position, in consultation ≥ 140/90 and ≤180/110 mmHg during the selection visit (D0) - despite taking 0-2 antihypertensive treatment(s) stably for at least 4 weeks
  • Person able to understand and agree to follow all study procedures
  • Person who is affiliated or beneficiary of a social security plan

Exclusion 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

Sites / Locations

  • CHU de Bordeaux - Hôpital Saint-AndréRecruiting
  • CHU Grenoble-AlpesRecruiting
  • CHRU de LILLE - Hôpital Cardiologique
  • CHU de Nantes - Hôpital LaennecRecruiting
  • APHP - Hôpital Européen Georges-PompidouRecruiting
  • CHU de TOULOUSE - Hôpital Rangueil

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Denervation treatment

Control

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Number of adverse events
Number of adverse events following denervation compared to the control procedure between Day 0 and 1 month after end of pregnancy ( 70 months maximum)
Number of potential pregnancy complications
Number of potential pregnancy complications between Day 0 and 1 month after end of pregnancy ( 70 months maximum)
Comparison of 24-hour ABPM variations
Comparison of 24-hour ABPM variations between Day 30 and 1 month after end of pregnancy ( 70 months maximum)
Comparison of Home BP variations
Comparison of Home BP variations between Day 30 and 1 month after end of pregnancy ( 70 months maximum)
Number of antihypertensive treatments used

Full Information

First Posted
August 24, 2022
Last Updated
August 28, 2023
Sponsor
University Hospital, Bordeaux
search

1. Study Identification

Unique Protocol Identification Number
NCT05563337
Brief Title
Women Hypertensive and Young-Renal Denervation
Acronym
WHY-RDN
Official Title
Renal Denervation in Hypertensive Women Planning to Become Pregnant
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2023 (Actual)
Primary Completion Date
May 18, 2025 (Anticipated)
Study Completion Date
November 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 .
Detailed Description
Investigators will include women with essential hypertension, treated or untreated, who are planning a short term pregnancy (D0). If high blood pressure is confirmed by ABPM after one month without treatment (D30), investigators will proceed to the arteriography during which they will be randomized in the renal denervation group or in the control one. After the randomization, BP monitoring by Home BP measurement will be performed every month and send to the investigator. Then the patient will benefit from a new ABPM two months after the intervention (D100), and she may stop contraception and may become pregnant. BP will be monitored during pregnancy by home BP and by a new ABPM at the beginning of the 6th month of pregnancy as well as one, one month after delivery. From the D100, the patient will be able to start an antihypertensive treatment at any time depending on HBPM or ABPM.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Hypertension
Keywords
Renal denervation, Pregnancy, Arterial hypertension

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Denervation treatment
Arm Type
Experimental
Arm Title
Control
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
Arteriography and renal denervation
Intervention Description
Diagnostic renal Arteriography - Randomization - Renal denervation
Intervention Type
Procedure
Intervention Name(s)
Arteriography without renal denervation
Intervention Description
Diagnostic renal Arteriography - Randomization
Primary Outcome Measure Information:
Title
Normalization of 24h blood pressure
Description
Percentage of patients cured of their hypertension (cure defined as 24h BP<130/80 mmHg at Day 100 without treatment)
Time Frame
at Day 100
Secondary Outcome Measure Information:
Title
Number of adverse events
Description
Number of adverse events following denervation compared to the control procedure between Day 0 and 1 month after end of pregnancy ( 70 months maximum)
Time Frame
between Day 0 and 70 months
Title
Number of potential pregnancy complications
Description
Number of potential pregnancy complications between Day 0 and 1 month after end of pregnancy ( 70 months maximum)
Time Frame
between Day 0 and 70 months
Title
Comparison of 24-hour ABPM variations
Description
Comparison of 24-hour ABPM variations between Day 30 and 1 month after end of pregnancy ( 70 months maximum)
Time Frame
between Day 30 and 70 months
Title
Comparison of Home BP variations
Description
Comparison of Home BP variations between Day 30 and 1 month after end of pregnancy ( 70 months maximum)
Time Frame
between Day 30 and 70 months
Title
Number of antihypertensive treatments used
Time Frame
at Day 100

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe GOSSE, MD
Phone
05 56 79 58 89
Ext
+33
Email
philippe.gosse@chu-bordeaux.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julie GAUDISSARD
Phone
05 57 82 08 01
Ext
+33
Email
julie.gaudissard@chu-bordeaux.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe GOSSE, MD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Study Director
Facility Information:
Facility Name
CHU de Bordeaux - Hôpital Saint-André
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe GOSSE, MD
Phone
05 56 79 58 89
Ext
+33
Email
philippe.gosse@chu-bordeaux.fr
Facility Name
CHU Grenoble-Alpes
City
Grenoble
ZIP/Postal Code
38043 Cedex 9
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier ORMEZZANO, MD,PhD
Phone
04 76 76 54 40
Ext
+ 33
Email
OOrmezzano@chu-grenoble.fr
Facility Name
CHRU de LILLE - Hôpital Cardiologique
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal DELSART, MD
Phone
03 20 44 59 62
Ext
+33
Email
Pascal.DELSART@chru-lille.fr
Facility Name
CHU de Nantes - Hôpital Laennec
City
Nantes
ZIP/Postal Code
44093 cedex 1
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume LAMIRAULT, MD
Phone
02 40 16 51 02
Ext
+ 33
Email
guillaume.lamirault@univ-nantes.fr
Facility Name
APHP - Hôpital Européen Georges-Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel AZIZI, MD,PhD
Phone
01 56 09 37 73
Ext
+33
Email
michel.azizi@aphp.fr
Facility Name
CHU de TOULOUSE - Hôpital Rangueil
City
Toulouse
ZIP/Postal Code
31059 Cedex 9
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Béatrice DULY-BOUHANICK, MD
Phone
05 61 32 21 59
Ext
+33
Email
duly-bouhanick.b@chu-toulouse.fr

12. IPD Sharing Statement

Learn more about this trial

Women Hypertensive and Young-Renal Denervation

We'll reach out to this number within 24 hrs