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

May 3, 2018 updated by: University Hospital, Grenoble

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Isère
      • Grenoble, Isère, France, 38043
        • University Hospital
      • La Tronche, Isère, France, 38700
        • Grenoble Association for the Dialysis of Uremic Chronicles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Renal sympathicolysis

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
Other Names:
  • renal sympathetic denervation
  • CT guidance
Procedure: Ambulatory Blood Pressure Monitoring
1 month before and after surgery the patient will have an ABPM over 24h
Other Names:
  • ABPM
Radiation: Magnetic Resonance Angiography
1 month before and after surgery the patient will have a MRA
Other Names:
  • MRA
Biological: Blood test
complete blood count, blood platelets, coagulation profile, irregular agglutinins search

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success or failure of the peri-arterial technique injection of ethanol under CT guidance.
Time Frame: 2 hours

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Time Frame: One 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
Change of the blood pressure between baseline and 1 month after surgery The results of this difference is in mmHg.
Time Frame: baseline at one month before surgery and 1 month after surgery
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
Duration of the procedure between the first scanner acquisition and the latest acquisition of control. The result is in minutes.
Time Frame: 2 hours
Assess the duration of the chemical sympatholysis procedure by translumbar access under CT guidance
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.
Time Frame: One month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Julien Ghelfi, Md, University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

January 5, 2016

First Submitted That Met QC Criteria

January 8, 2016

First Posted (Estimate)

January 12, 2016

Study Record Updates

Last Update Posted (Actual)

May 9, 2018

Last Update Submitted That Met QC Criteria

May 3, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC15.182
  • 2015-002579-59 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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