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

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Terminated; Phase 2

Conditions: Hypertension Resistant to Conventional Therapy; Kidney Failure, Chronic

Treatments: Procedure: Renal sympathicolysis; Radiation: Magnetic Resonance Angiography; Procedure: Ambulatory Blood Pressure Monitoring; Biological: Blood test

Study type: Interventional

Funder types: Other

Identifiers

NCT02653222

38RC15.182

2015-002579-59 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Renal sympathicolysis

Experimental group

Description:

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

Treatment:

Procedure: Ambulatory Blood Pressure Monitoring

Radiation: Magnetic Resonance Angiography

Procedure: Renal sympathicolysis

Biological: Blood test