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

Primary Purpose

Hypertension Resistant to Conventional Therapy, Kidney Failure, Chronic

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Renal sympathicolysis
Ambulatory Blood Pressure Monitoring
Magnetic Resonance Angiography
Blood test
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension Resistant to Conventional Therapy focused on measuring Ethanol Sympathicolysis, Computer Tomography guidance, Denervation, Kidney Transplantation, Dialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital
  • Grenoble Association for the Dialysis of Uremic Chronicles

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Renal sympathicolysis

Arm Description

The patient will have: Ambulatory Blood Pressure Monitoring Magnetic Resonance Angiography Blood test Renal sympathicolysis Ambulatory Blood Pressure Monitoring Magnetic Resonance Angiography

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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
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).

Full Information

First Posted
January 5, 2016
Last Updated
May 3, 2018
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02653222
Brief Title
Chemical Renal Ethanol Sympatholysis Under CT Guidance Use for the Control of Therapy-Resistant Hypertension
Acronym
SCRATCH
Official Title
Feasibility Study of Perivascular Computer Tomography-guided Ethanol Sympatholysis for the Treatment of Therapy-resistant Arterial Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
patient recruitment is difficult
Study Start Date
February 2016 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension Resistant to Conventional Therapy, Kidney Failure, Chronic
Keywords
Ethanol Sympathicolysis, Computer Tomography guidance, Denervation, Kidney Transplantation, Dialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Renal sympathicolysis
Arm Type
Experimental
Arm Description
The patient will have: Ambulatory Blood Pressure Monitoring Magnetic Resonance Angiography Blood test Renal sympathicolysis Ambulatory Blood Pressure Monitoring Magnetic Resonance Angiography
Intervention Type
Procedure
Intervention Name(s)
Renal sympathicolysis
Other Intervention Name(s)
renal sympathetic denervation, CT guidance
Intervention Type
Procedure
Intervention Name(s)
Ambulatory Blood Pressure Monitoring
Other Intervention Name(s)
ABPM
Intervention Description
1 month before and after surgery the patient will have an ABPM over 24h
Intervention Type
Radiation
Intervention Name(s)
Magnetic Resonance Angiography
Other Intervention Name(s)
MRA
Intervention Description
1 month before and after surgery the patient will have a MRA
Intervention Type
Biological
Intervention Name(s)
Blood test
Intervention Description
complete blood count, blood platelets, coagulation profile, irregular agglutinins search
Primary Outcome Measure Information:
Title
Success or failure of the peri-arterial technique injection of ethanol under CT guidance.
Description
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
Secondary Outcome Measure Information:
Title
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).
Description
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
Title
Change of the blood pressure between baseline and 1 month after surgery The results of this difference is in mmHg.
Description
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
Title
Duration of the procedure between the first scanner acquisition and the latest acquisition of control. The result is in minutes.
Description
Assess the duration of the chemical sympatholysis procedure by translumbar access under CT guidance
Time Frame
2 hours
Title
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.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien Ghelfi, Md
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Grenoble
State/Province
Isère
ZIP/Postal Code
38043
Country
France
Facility Name
Grenoble Association for the Dialysis of Uremic Chronicles
City
La Tronche
State/Province
Isère
ZIP/Postal Code
38700
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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