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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002579-59 | EudraCT Number |
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patient recruitment is difficult
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In this study the investigators are going to assess the feasibility of this innovate technique of renal sympathetic denervation by translumbar access under ct-guidance.
To limit the potential impact on the kidney, the investigators chose a population of chronic renal failure patients on dialysis or renal transplant (with native kidneys still present) and having resistant treatment hypertension despite antihypertensive combination therapy well conducted.
The investigators expect to obtain a decrease of the blood pressure at the 24-hours ambulatory blood pressure monitoring (ABPM) one month after the sympathetic denervation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal sympathicolysis | Experimental | The patient will have:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal sympathicolysis | Procedure |
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| |
| Measure | Description | Time Frame |
|---|---|---|
| Success or failure of the peri-arterial technique injection of ethanol under CT guidance. | Assess the technical feasibility of a new procedure of renal denervation chemical sympatholysis with ethanol, by a translumbar access, guided by CT, in a population of chronic dialysis or transplant failure patients followed for resistant treatment hypertension. The measure is a score based on the distribution of the ethanol near the aorta-renal angle | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Any clinical adverse event, radiological or biological related to the procedure and between it and the end of the study (MRI and follow up to 1 month). | Assess the occurrence of adverse events in the population who received the intervention by chemical sympatholysis during the month following the intervention | One month |
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Inclusion Criteria:
No Inclusion Criteria:
renal artery anatomy against-indicating the procedure including:
3 homolateral renal arteries
kidney surgery including bypass surgery or renal artery reimplantation
volume-dependent type of hypertension
secondary hypertension (not included nephropathy)
orthostatic hypotension associated with symptoms during the previous year
medical history including:
anticoagulants or antiplatelet agents for which a therapeutic window can not be considered (except aspirin dose less than or equal to 160mg / day)
contraindication to the realization of an MRI
included in another trial assessing a medicament or a medical device or a surgical procedure
protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health
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| Name | Affiliation | Role |
|---|---|---|
| Julien Ghelfi, Md | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Grenoble | Isère | 38043 | France | ||
| Grenoble Association for the Dialysis of Uremic Chronicles |
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| Ambulatory Blood Pressure Monitoring |
| Procedure |
1 month before and after surgery the patient will have an ABPM over 24h |
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| Magnetic Resonance Angiography | Radiation | 1 month before and after surgery the patient will have a MRA |
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| Blood test | Biological | complete blood count, blood platelets, coagulation profile, irregular agglutinins search |
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| Change of the blood pressure between baseline and 1 month after surgery The results of this difference is in mmHg. |
Assess the effect of the chemical kidney sympatholysis on blood pressure one month after surgery. |
| baseline at one month before surgery and 1 month after surgery |
| Duration of the procedure between the first scanner acquisition and the latest acquisition of control. The result is in minutes. | Assess the duration of the chemical sympatholysis procedure by translumbar access under CT guidance | 2 hours |
| A score will be established with one point by angle aorto-renal upper cover and one point on each quarter of the circumference of renal artery covered with ethanol. | Assess at 1 month follow up the chemical sympatholysis effect on blood pressure based on the distribution of ethanol (visualized by prior injection of contrast medium). | One month |
| La Tronche |
| Isère |
| 38700 |
| France |
| ID | Term |
|---|---|
| C563514 | Hypertension Resistant to Conventional Therapy |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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