Skip to content

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

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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02653222
Acronym
SCRATCH
Enrollment
2
Registered
2016-01-12
Start date
2016-02-29
Completion date
2018-02-28
Last updated
2018-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension Resistant to Conventional Therapy, Kidney Failure, Chronic

Keywords

Ethanol Sympathicolysis, Computer Tomography guidance, Denervation, Kidney Transplantation, Dialysis

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.

Interventions

PROCEDURERenal sympathicolysis

1 month before and after surgery the patient will have an ABPM over 24h

RADIATIONMagnetic Resonance Angiography

1 month before and after surgery the patient will have a MRA

BIOLOGICALBlood test

complete blood count, blood platelets, coagulation profile, irregular agglutinins search

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Success or failure of the peri-arterial technique injection of ethanol under CT guidance.2 hoursAssess 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

Secondary

MeasureTime frameDescription
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).One monthAssess the occurrence of adverse events in the population who received the intervention by chemical sympatholysis during the month following the intervention
Change of the blood pressure between baseline and 1 month after surgery The results of this difference is in mmHg.baseline at one month before surgery and 1 month after surgeryAssess the effect of the chemical kidney sympatholysis on blood pressure one month after surgery.
Duration of the procedure between the first scanner acquisition and the latest acquisition of control. The result is in minutes.2 hoursAssess the duration of the chemical sympatholysis procedure by translumbar access under CT guidance
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.One monthAssess 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).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026