Renal Sympathectomy in Treatment Resistant Essential Hypertension, a Sham Controlled Randomized Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-02-28

Brief Summary

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The purpose of this double blind, randomized and sham controlled study is to determine whether renal denervation in terms of catheter based ablation in the renal arteries is effective in lowering blood pressure in patients with treatment resistant hypertension. The blood pressure lowering effect will be evaluated by 24 hours ambulatory blood pressure measurement at baseline and after 1, 3 and 6 months of follow up. Secondary end point evaluation concerns hemodynamic measures using echocardiography, applanation tonometry and forearm plethysmography.

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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Renal artery ablation

By femoral access, coronary and renal angiography are performed. The patient will be sedated. In case of vessel anatomy allowing renal ablation, the patient will be randomized in the card. lab. In case of randomization to active treatment, renal artery ablation will be carried out straight away.

Group Type ACTIVE_COMPARATOR

Renal artery ablation

Intervention Type PROCEDURE

Catheter based renal denervation by applying low power radiofrequency to the renal artery using the Ardian Medtronic Simplicity Catheter, introduced by femoral artery access.

Sham

By femoral access, coronary and renal angiography are performed. The patient will be sedated. In case of vessel anatomy allowing renal ablation, the patient will be randomized in the card. lab. In case of randomization to sham procedure, no renal artery ablation are performed.

Group Type SHAM_COMPARATOR

Renal angiography

Intervention Type PROCEDURE

Renal angiography by femoral access.

Interventions

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Renal artery ablation

Catheter based renal denervation by applying low power radiofrequency to the renal artery using the Ardian Medtronic Simplicity Catheter, introduced by femoral artery access.

Intervention Type PROCEDURE

Renal angiography

Renal angiography by femoral access.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Systolic daytime ambulatory BP at least 145 mmHg and compliance to a minimum of 3 antihypertensive drugs, including a diuretic, or in case of diuretic intolerance at least 3 nondiuretic antihypertensive drugs.

Exclusion Criteria

* Pregnancy
* Non compliance
* Heart Failure (NYHA 3-4)
* LV ejection fraction \< 50 %
* Renal insufficiency (eGFR\<30)
* Unstable coronary heart disease
* Coronary intervention within 6 months
* Myocardial infarction within 6 months
* Claudication
* Orthostatic syncope within 6 months
* Secondary Hypertension
* Permanent atrial fibrillation
* Significant Heart Valve Disease
* Clinically Significant abnormal electrolytes, haemoglobin, Liver enzymes, TSH
* Second and third degree heart block
* Macroscopic haematuria
* Proximal significant coronary stenosis
* Renal artery anatomy not suitable for renal artery ablation (Stenosis, small diameter \< 4 mm, length \< 2 cm, multiple renal arteries, severe calcifications)

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No