Clinical trial NCT02653222: Chemical Renal Ethanol Sympatholysis Under CT Guidance Use for the Control of Therapy-Resistant Hypertension
Official title: Feasibility Study of Perivascular Computer Tomography-guided Ethanol Sympatholysis for the Treatment of Therapy-resistant Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hypertension Resistant to Conventional Therapy
Kidney Failure, Chronic
Keywords: Ethanol Sympathicolysis
Computer Tomography guidance
Denervation
Kidney Transplantation
Dialysis
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-01-12
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Success or failure of the peri-arterial technique injection of ethanol under CT guidance.
timeFrame: 2 hours
Secondary outcomes:
measure: 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).
timeFrame: One month
measure: Change of the blood pressure between baseline and 1 month after surgery The results of this difference is in mmHg.
timeFrame: baseline at one month before surgery and 1 month after surgery
measure: Duration of the procedure between the first scanner acquisition and the latest acquisition of control. The result is in minutes.
timeFrame: 2 hours
measure: 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.
timeFrame: One month
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital
state: Isère
city: La Tronche
country: France
facility: Grenoble Association for the Dialysis of Uremic Chronicles
state: Isère
Study officials:
affiliation: University Hospital, Grenoble
name: Julien Ghelfi, Md
role: PRINCIPAL_INVESTIGATOR
References: