A Phase 2 interventional study of Renal sympathicolysis and Ambulatory Blood Pressure Monitoring in Hypertension Resistant to Conventional Therapy and Kidney Failure, Chronic, sponsored by University Hospital, Grenoble. Terminated at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-09.
Sponsored by University Hospital, Grenoble · Phase 2, Interventional, and Treatment
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.
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's enrollment of 2 is below the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.
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Inclusion Criteria:
No Inclusion Criteria:
medical history including:
The patient will have: 1. Ambulatory Blood Pressure Monitoring 2. Magnetic Resonance Angiography 3. Blood test 4. Renal sympathicolysis 5. Ambulatory Blood Pressure Monitoring 6. Magnetic Resonance Angiography
Procedure: Renal sympathicolysis · Procedure: Ambulatory Blood Pressure Monitoring · Radiation: Magnetic Resonance Angiography · Biological: Blood test
Also known as: renal sympathetic denervation, CT guidance
1 month before and after surgery the patient will have an ABPM over 24h
Also known as: ABPM
1 month before and after surgery the patient will have a MRA
Also known as: MRA
complete blood count, blood platelets, coagulation profile, irregular agglutinins search
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
Time frame: 2 hours
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
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: One month
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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University Hospital, Grenoble