Renal Denervation in Treatment Resistant Hypertension

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 investigate the blood pressure lowering effect of renal denervation by catheter based ablation in the renal arteries in patients with milder forms of treatment resistant hypertension. The effect on blood pressure will be evaluated by 24-hour ambulatory blood pressure measurements at baseline and after 3 and 6 months of follow up. Secondary endpoint evaluation comprises hemodynamic assessment by applanation tonometry and the cold pressor response.

Official Title
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Renal Denervation in Treatment Resistant Hypertension, a Double-blind Randomized Controlled Trial

Conditions
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Hypertension

Intervention / Treatment
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* Procedure: Ablation of the renal arteries
* Procedure: Renal angiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systolic daytime (24 hour-ambulatory blood pressure measurement) > 135 mmHg and < 145 mmHg. Stable (for at least 1 month and with no planned changes for the next 6 months) antihypertensive therapy with at least 3 antihypertensive drugs, including a diuretic. Documented adherence to present antihypertensive therapy Exclusion Criteria: Pregnancy Non compliance Heart failure (NYHA Class III-IV) LV ejection fraction < 50 % Renal insufficiency (eGFR<30 ml/min) Unstable coronary heart disease Coronary intervention within 6 months Myocardial infarction within 6 months Claudication Orthostatic syncope within 6 months Secondary hypertension (except CKD) Significant valvular heart disease Clinically significant biochemical abnormalities (electrolytes, haemoglobin, hepatic function, thyroid) Second and third degree AV block Macroscopic haematuria Renal artery anatomy not suitable for renal artery ablation (Stenosis, diameter < 4 mm, length < 2 cm or severe calcifications) Moderate/severe obstructive sleep apnoea (AHI > 15) if CPAP treatment has not been attempted

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Renal denervation by ablation of the renal arteries<br>By femoral access, renal angiography is performed. The patient will be sedated. In case of acceptable renal artery anatomy allowing renal ablation, the patient will be randomized in the cath. lab. If randomized to active treatment, renal artery ablation will be carried out straight away. | Procedure: Ablation of the renal arteries<br>* Catheter-based renal denervation by applying low power radiofrequency to the renal artery using the EnligHTN Catheter, introduced by femoral artery access.<br>|
| Sham Comparator: Control<br>By femoral access, renal angiography is performed. The patient will be sedated. In case of acceptable renal artery anatomy allowing renal ablation, the patient will be randomized in the cath. lab. If randomized to sham treatment, the procedure stops. | 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 |
| --- | --- | --- |
| Change from baseline in daytime systolic blood pressure (24-hour ambulatory blood pressure measurement) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in blood pressure (clinic and 24-hour ambulatory blood pressure measurement) |  | 3 and 6 months | 
| Change from baseline in central blood pressure, augmentation index and pulse wave velocity |  | 6 months | 
| Change from baseline in cold pressor response |  | 6 months | 
| Change from baseline in intensity of medical antihypertensive therapy |  | 1, 3 and 6 months | 
| Blood pressure (clinic measurement) |  | 1, 3 and 6 months | 
| Renal function (eGFR and electrolytes) |  | 1, 3 and 6 months | 

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