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

Kidney Failure, Chronic Clinical Trial

— SCRATCH  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02653222
• Other study ID #: 38RC15.182
• Secondary ID: 2015-002579-59
• Status: Terminated
• Phase: Phase 2
• Start date: February 2016
• Est. completion date: February 2018

Study information

• Verified date: May 2018
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Vasospasm
• Hypertension
• Hypertension Resistant to Conventional Therapy
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Procedure:
• Renal sympathicolysis

• Ambulatory Blood Pressure Monitoring
1 month before and after surgery the patient will have an ABPM over 24h

Radiation:
• Magnetic Resonance Angiography
1 month before and after surgery the patient will have a MRA

Biological:
• Blood test
complete blood count, blood platelets, coagulation profile, irregular agglutinins search

Locations

Country	Name	City	State
France	University Hospital	Grenoble	Isère
France	Grenoble Association for the Dialysis of Uremic Chronicles	La Tronche	Isère

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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