NCT02653222

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 12, 2016

Completed
20 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

Enrollment Period

2 years

First QC Date

January 5, 2016

Last Update Submit

May 3, 2018

Conditions

Hypertension Resistant to Conventional TherapyKidney Failure, Chronic

Keywords

Ethanol SympathicolysisComputer Tomography guidanceDenervationKidney TransplantationDialysis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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 month

  • 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 surgery

  • Duration of the procedure between the first scanner acquisition and the latest acquisition of control. The result is in minutes.

    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.

    One month

Study Arms (1)

Renal sympathicolysis

EXPERIMENTAL

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 sympathicolysisProcedure: Ambulatory Blood Pressure MonitoringRadiation: Magnetic Resonance AngiographyBiological: Blood test

Interventions

Renal sympathicolysisPROCEDURE
Also known as: renal sympathetic denervation, CT guidance
Renal sympathicolysis
Ambulatory Blood Pressure MonitoringPROCEDURE

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

Also known as: ABPM
Renal sympathicolysis
Magnetic Resonance AngiographyRADIATION

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

Also known as: MRA
Renal sympathicolysis
Blood testBIOLOGICAL

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

Renal sympathicolysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • renal artery anatomy against-indicating the procedure including:
  • 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:
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital

Grenoble, Isère, 38043, France

Location

Grenoble Association for the Dialysis of Uremic Chronicles

La Tronche, Isère, 38700, France

Location

MeSH Terms

Conditions

Hypertension Resistant to Conventional TherapyKidney Failure, Chronic

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Julien Ghelfi, Md

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2016

First Posted

January 12, 2016

Study Start

February 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

May 9, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)