Arterial HypertensionWHY-RDNNCT05563337
Women Hypertensive and Young-Renal Denervation
A study testing Arteriography and renal denervation and Arteriography without renal denervation in people with Arterial Hypertension, run by University Hospital, Bordeaux at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Arterial Hypertension
- What is being tested?
- Arteriography and renal denervation and Arteriography without renal denervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 6 sitesFrance
- Study dates
- 31 Jan 2023to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ≥ 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),
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
CHU de Bordeaux - Hôpital Saint-André
Bordeaux
Philippe GOSSE, MD, 05 56 79 58 89 ext. +33, philippe.gosse@chu-bordeaux.fr
- Recruiting
CHU Grenoble-Alpes
Grenoble, 38043 Cedex 9
Olivier ORMEZZANO, MD,PhD, 04 76 76 54 40 ext. + 33, OOrmezzano@chu-grenoble.fr
- Not yet recruiting
CHRU de LILLE - Hôpital Cardiologique
Lille, 59037
Pascal DELSART, MD, 03 20 44 59 62 ext. +33, Pascal.DELSART@chru-lille.fr
- Recruiting
CHU de Nantes - Hôpital Laennec
Nantes, 44093 cedex 1
Guillaume LAMIRAULT, MD, 02 40 16 51 02 ext. + 33, guillaume.lamirault@univ-nantes.fr
- Recruiting
APHP - Hôpital Européen Georges-Pompidou
Paris, 75015
Michel AZIZI, MD,PhD, 01 56 09 37 73 ext. +33, michel.azizi@aphp.fr
- Not yet recruiting
CHU de TOULOUSE - Hôpital Rangueil
Toulouse, 31059 Cedex 9
Béatrice DULY-BOUHANICK, MD, 05 61 32 21 59 ext. +33, duly-bouhanick.b@chu-toulouse.fr
About this study
Official title: Renal Denervation in Hypertensive Women Planning to Become Pregnant
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 .
Read the 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.
- Conditions
- Arterial Hypertension
- Being tested
- Arteriography and renal denervation, Arteriography without renal denervation
- Keywords
- Renal denervation, Pregnancy, Arterial hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arteriography and renal denervationProcedure or surgery
Diagnostic renal Arteriography - Randomization - Renal denervation
Arteriography without renal denervationProcedure or surgery
Diagnostic renal Arteriography - Randomization
| Study group | Role | What they receive |
|---|---|---|
| Denervation treatment | Experimental | Not described Receives: Procedure: Arteriography and renal denervation |
| Control | Sham comparator | Not described Receives: Procedure: Arteriography without renal denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: at Day 100
Secondary outcomes (5)
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)
Measured: between Day 0 and 70 months
Number of potential pregnancy complications
Number of potential pregnancy complications between Day 0 and 1 month after end of pregnancy ( 70 months maximum)
Measured: between Day 0 and 70 months
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)
Measured: between Day 30 and 70 months
Comparison of Home BP variations
Comparison of Home BP variations between Day 30 and 1 month after end of pregnancy ( 70 months maximum)
Measured: between Day 30 and 70 months
Number of antihypertensive treatments used
Measured: at Day 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start31 Jan 2023
- Primary completion18 May 2025 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe GOSSE, MD, Study director, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563337
- Sponsor's protocol ID
- CHUBX 2020/56
- Other IDs
- 2021-A02309-32
- Acronym
- WHY-RDN
- Status last verified
- Aug 2022
- First submitted
- 24 Aug 2022
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37775290
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Denervation in Hypertensive Women Planning to Become Pregnant
- ClinicalTrials.gov ID
- NCT05563337
- Acronym / sponsor ID
- WHY-RDN / CHUBX 2020/56
- Conditions
- Arterial Hypertension
- Keywords
- Renal denervation, Pregnancy, Arterial hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 18 May 2025 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Denervation treatment | Experimental | Procedure: Arteriography and renal denervation |
| Control | Sham comparator | Procedure: Arteriography without renal denervation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (36 listed)
- ≥ 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
Key exclusion criteria (16 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arteriography and renal denervationDiagnostic renal Arteriography - Randomization - Renal denervation | Procedure or surgery | Denervation treatment |
| Arteriography without renal denervationDiagnostic renal Arteriography - Randomization | Procedure or surgery | Control |
Primary outcome
Normalization of 24h blood pressure
Time frame: at Day 100
Percentage of patients cured of their hypertension (cure defined as 24h BP<130/80 mmHg at Day 100 without treatment)
5 secondary outcomes
Number of adverse events
Time frame: between Day 0 and 70 months
Number of potential pregnancy complications
Time frame: between Day 0 and 70 months
Comparison of 24-hour ABPM variations
Time frame: between Day 30 and 70 months
Comparison of Home BP variations
Time frame: between Day 30 and 70 months
Number of antihypertensive treatments used
Time frame: at Day 100
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Derived from this study: PubMed 37775290Gosse 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philippe GOSSE, MD study director
University Hospital, Bordeaux
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arteriography and renal denervation and Arteriography without renal denervation in people with Arterial Hypertension, run by University Hospital, Bordeaux at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 36 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippe GOSSE, MD (05 56 79 58 89 ext. +33, philippe.gosse@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normalization of 24h blood pressure (time frame: at Day 100). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05563337, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.