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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiofrequency main renal artery | Active Comparator | Renal sympathetic denervation of the main renal artery using the radiofrequency-based Spyral™ catheter (Medtronic, MN, USA) |
|
| Radiofrequency main and branches | Experimental | Renal sympathetic denervation of the main renal artery, its branches and accessories using the radiofrequency-based Spyral™ catheter (Medtronic, MN, USA) |
|
| Ultrasound main renal artery | Experimental | Renal sympathetic denervation of the main renal artery using the ultrasound-based Paradise™ catheter (ReCor, CA, USA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency denervation of the main renal arteries | Device | Catheter based renal sympathetic denervation of the main renal arteries using the Spyral™ Catheter (Medtronic, MN, USA) |
| Measure | Description | Time Frame |
|---|---|---|
| Daytime blood pressure change | Daytime blood pressure change in ambulatory blood pressure measurement | 3 months after Intervention |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philipp C Lurz, MD, PhD | Heart Center of the University Leipzig | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Center of the University Leipzig | Leipzig | 04289 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36792266 | Derived | Fengler K, Rommel KP, Kriese W, Blazek S, Besler C, von Roeder M, Desch S, Thiele H, Lurz P. 6- and 12-Month Follow-Up From a Randomized Clinical Trial of Ultrasound vs Radiofrequency Renal Denervation (RADIOSOUND-HTN). JACC Cardiovasc Interv. 2023 Feb 13;16(3):367-369. doi: 10.1016/j.jcin.2022.10.058. No abstract available. | |
| 31203726 |
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| Radiofrequency denervation of renal arteries and branches | Device | Catheter based renal sympathetic denervation of the main renal arteries and its branches using the Spyral™ Catheter (Medtronic, MN, USA) |
|
| Ultrasound denervation of the main renal arteries | Device | Catheter based renal sympathetic denervation of the main renal arteries using the Paradise™ Catheter (ReCor Medical, CA, USA) |
|
| 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 |
| Fengler K, Rommel KP, Lapusca R, Blazek S, Besler C, Hartung P, von Roeder M, Kresoja KP, Desch S, Thiele H, Lurz P. Renal Denervation in Isolated Systolic Hypertension Using Different Catheter Techniques and Technologies. Hypertension. 2019 Aug;74(2):341-348. doi: 10.1161/HYPERTENSIONAHA.119.13019. Epub 2019 Jun 17. |
| 30586691 | Derived | Fengler K, Rommel KP, Blazek S, Besler C, Hartung P, von Roeder M, Petzold M, Winkler S, Hollriegel R, Desch S, Thiele H, Lurz P. A Three-Arm Randomized Trial of Different Renal Denervation Devices and Techniques in Patients With Resistant Hypertension (RADIOSOUND-HTN). Circulation. 2019 Jan 29;139(5):590-600. doi: 10.1161/CIRCULATIONAHA.118.037654. |