Chemical Renal Ethanol Sympatholysis Under CT Guidance Use for the Control of Therapy-Resistant Hypertension

Study Overview
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Brief Summary
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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.

Official Title
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Feasibility Study of Perivascular Computer Tomography-guided Ethanol Sympatholysis for the Treatment of Therapy-resistant Arterial Hypertension

Conditions
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Hypertension Resistant to Conventional Therapy, Kidney Failure, Chronic

Intervention / Treatment
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* Procedure: Renal sympathicolysis
* Procedure: Ambulatory Blood Pressure Monitoring
* Radiation: Magnetic Resonance Angiography
* Biological: Blood test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: more or equal than 18 years old, patient with triple antihypertensive therapy (maximum tolerated dose) with a diuretic, except for anuric patients, and without modification treatment: in the last two months, expected in the next three months, renal transplanted patients with native kidneys followed for hypertension before transplant, and having a arterial systolic pressure ≥ 160 mmHg on the average of 3 measurements taken during the screening consultation and during at least one previous consultation OR chronic renal failure patient with dialysis and having a arterial systolic pressure ≥ 160 mmHg on the average of 3 measurements taken during the screening consultation and during at least one previous consultation patient affiliated to social security or similarly regime patient who signed the consent to participate in the study 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: acute coronary syndrome, unstable angina, stroke within 6 months preceding the period of inclusion, surgery scheduled on the kidney, the renal arteries or the retroperitoneum during patient participation in the study period chronic alcoholism 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal sympathicolysis<br>The patient will have: Ambulatory Blood Pressure Monitoring Magnetic Resonance Angiography Blood test Renal sympathicolysis Ambulatory Blood Pressure Monitoring Magnetic Resonance Angiography | Procedure: Renal sympathicolysis<br> <br> * Other names: CT guidance;Procedure: Ambulatory Blood Pressure Monitoring<br>* 1 month before and after surgery the patient will have an ABPM over 24h<br>* Other names: ABPM;Radiation: Magnetic Resonance Angiography<br>* 1 month before and after surgery the patient will have a MRA<br>* Other names: MRA;Biological: Blood test<br>* complete blood count, blood platelets, coagulation profile, irregular agglutinins search<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dialysis, Ethanol Sympathicolysis, Computer Tomography guidance, Denervation, Kidney Transplantation