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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A02309-32 | Other Identifier | ID RCB |
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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 .
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Denervation treatment | Experimental |
| |
| Control | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arteriography and renal denervation | Procedure | Diagnostic renal Arteriography - Randomization - Renal denervation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | between Day 0 and 70 months |
| Number of potential pregnancy complications |
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Inclusion Criteria:
Non-Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philippe GOSSE, MD | Contact | 05 56 79 58 89 | +33 | philippe.gosse@chu-bordeaux.fr |
| Julie GAUDISSARD | Contact | 05 57 82 08 01 | +33 | julie.gaudissard@chu-bordeaux.fr |
| Name | Affiliation | Role |
|---|---|---|
| Philippe GOSSE, MD | University Hospital, Bordeaux | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux - Hôpital Saint-André | Recruiting | Bordeaux | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37775290 | Derived | 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. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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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
| Arteriography without renal denervation | Procedure | Diagnostic renal Arteriography - Randomization |
|
Number of potential pregnancy complications between Day 0 and 1 month after end of pregnancy ( 70 months maximum)
| 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) | 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) | between Day 30 and 70 months |
| Number of antihypertensive treatments used | at Day 100 |
| CHU Grenoble-Alpes | Recruiting | Grenoble | 38043 Cedex 9 | France |
|
| CHRU de LILLE - Hôpital Cardiologique | Not yet recruiting | Lille | 59037 | France |
|
| CHU de Nantes - Hôpital Laennec | Recruiting | Nantes | 44093 cedex 1 | France |
|
| APHP - Hôpital Européen Georges-Pompidou | Recruiting | Paris | 75015 | France |
|
| CHU de TOULOUSE - Hôpital Rangueil | Not yet recruiting | Toulouse | 31059 Cedex 9 | France |
|