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

Study Overview
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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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Procedure: Renal artery ablation
* Procedure: Renal angiography


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Renal artery ablation<br>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. | Procedure: Renal artery ablation<br>* Catheter based renal denervation by applying low power radiofrequency to the renal artery using the Ardian Medtronic Simplicity Catheter, introduced by femoral artery access.<br>|
| Sham Comparator: Sham<br>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. | Procedure: Renal angiography<br>* Renal angiography by femoral access.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| daytime systolic blood pressure assessed by 24 hours ambulatory BP measurement | Changes in mean daytime systolic BP after 3 months is compared between groups. Also the proportion of responders versus nonresponders after 3 months is compared between groups, responders being defined as A) a minimum decrease in daytime systolic BP of 10 mmHg analysis together with and unchanged/increased number of antihypertensive drugs, or B) a decrease in daytime systolic BP of 0-10 mmHg together with a reduced number of antihypertensive drugs. | 3 months follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ambulatory 24 hours BP measurements | Systolic, diastolic and mean Blood Pressures at different time points. Daytime and night time BP, dipping status, morning BP surge and BP variation. | 1, 3 and 6 months | 
| Echocardiography | Coronary flow reserve (LAD), Diastolic and Systolic ventricular function. LV hypertrophy. | 6 months | 
| Biomarkers | Biomarkers concerning renal sodium excretion | 1 months | 
| Applanation tonometry | Pulse wave velocity, augmentation index, central BP estimates | 6 months | 
| forearm plethysmography | Forearm minimum vascular resistance | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment Resistant Hypertension