Randomized Comparison of Ultrasound Versus Radiofrequency Denervation in Patients With Therapy Resistant Hypertension

Study Overview
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Brief Summary
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Prospective, randomized trial to assess the effectiveness of different renal sympathetic denervation methods (radiofrequency main vs. branches + main vs. ultrasound based) in a cohort of patients with therapy refractory arterial hypertension and large renal arteries

Detailed Description
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The aim of this trial is a prospective, randomized comparison of three different techniques for catheter based renal sympathetic denervation. Patients with larger (>5.5 mm) renal arteries are randomized to a treatment with a radiofrequency based catheter of the main renal artery, the main renal artery, its side-branches and accessories or an ultrasound-based denervation of the main renal artery only. The primary endpoint is the change in daytime blood pressure acquired in ambulatory blood pressure measurement at 3 months.

Official Title
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A Randomized Comparison of Ultrasound Based Versus Radiofrequency Based Catheter Ablation Techniques in Patients With Therapy Resistant Arterial Hypertension With Large Renal Arteries

Conditions
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Therapy Resistant Hypertension

Intervention / Treatment
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* Device: Radiofrequency denervation of the main renal arteries
* Device: Radiofrequency denervation of renal arteries and branches
* Device: Ultrasound denervation of the main renal arteries


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with resistant hypertension (≥3 antihypertensive drugs including at least one diuretic, without any dosage change in the preceding 4 weeks) and a systolic office blood pressure of >160 mmHg, ≥1 main renal artery diameter >5.5 mm Exclusion Criteria: pregnancy, known renal artery stenosis, average systolic daytime RR <135 mmHg in 24h ambulatory blood pressure measurement (ABPM), ≥1 renal artery diameter <4.0 mm, life-expectancy <6 months, participation in any other clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Radiofrequency main renal artery<br>Renal sympathetic denervation of the main renal artery using the radiofrequency-based Spyral™ catheter (Medtronic, MN, USA) | Device: Radiofrequency denervation of the main renal arteries<br>* Catheter based renal sympathetic denervation of the main renal arteries using the Spyral™ Catheter (Medtronic, MN, USA)<br>|
| Experimental: Radiofrequency main and branches<br>Renal sympathetic denervation of the main renal artery, its branches and accessories using the radiofrequency-based Spyral™ catheter (Medtronic, MN, USA) | Device: Radiofrequency denervation of renal arteries and branches<br>* Catheter based renal sympathetic denervation of the main renal arteries and its branches using the Spyral™ Catheter (Medtronic, MN, USA)<br>|
| Experimental: Ultrasound main renal artery<br>Renal sympathetic denervation of the main renal artery using the ultrasound-based Paradise™ catheter (ReCor, CA, USA) | Device: Ultrasound denervation of the main renal arteries<br>* Catheter based renal sympathetic denervation of the main renal arteries using the Paradise™ Catheter (ReCor Medical, CA, USA)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daytime blood pressure change | Daytime blood pressure change in ambulatory blood pressure measurement | 3 months after Intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General blood pressure change | Change in 24 h average blood pressure change in ambulatory blood pressure measurement | 3 months after Intervention | 
| Daytime blood pressure change | Daytime blood pressure change in ambulatory blood pressure measurement | 6 months after Intervention | 
| General blood pressure change | Change in 24 h average blood pressure change in ambulatory blood pressure measurement | 6 months after Intervention | 
| Daytime blood pressure change | Daytime blood pressure change in ambulatory blood pressure measurement | 12 months after Intervention | 
| Daytime blood pressure change | Daytime blood pressure change in ambulatory blood pressure measurement | 24 months after Intervention | 
| General blood pressure change | Change in 24 h average blood pressure change in ambulatory blood pressure measurement | 12 months after Intervention | 
| General blood pressure change | Change in 24 h average blood pressure change in ambulatory blood pressure measurement | 24 months after Intervention | 
| Exercise blood pressure change | Change in exercise blood pressure on bicycle stress testing | 3 months after Intervention |