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

Heart Center Leipzig - University Hospital

Status: Completed

Conditions: Therapy Resistant Hypertension

Treatments: Device: Radiofrequency denervation of the main renal arteries; Device: Ultrasound denervation of the main renal arteries; Device: Radiofrequency denervation of renal arteries and branches

Study type: Interventional

Funder types: Other

Identifiers

NCT02920034

Radiosound 1.1

Details and patient eligibility

About

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

Full description

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

Radiofrequency main renal artery

Active Comparator group

Description:

Renal sympathetic denervation of the main renal artery using the radiofrequency-based Spyral™ catheter (Medtronic, MN, USA)

Treatment:

Device: Radiofrequency denervation of the main renal arteries

Radiofrequency main and branches

Experimental group

Description:

Renal sympathetic denervation of the main renal artery, its branches and accessories using the radiofrequency-based Spyral™ catheter (Medtronic, MN, USA)

Treatment:

Device: Radiofrequency denervation of renal arteries and branches

Ultrasound main renal artery

Experimental group

Description:

Renal sympathetic denervation of the main renal artery using the ultrasound-based Paradise™ catheter (ReCor, CA, USA)

Treatment:

Device: Ultrasound denervation of the main renal arteries