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

Not Applicable

Completed

• Conditions: Therapy Resistant Hypertension
• Interventions: Device: Radiofrequency denervation of renal arteries and branches; Device: Radiofrequency denervation of the main renal arteries; Device: Ultrasound denervation of the main renal arteries

• Registration Number: NCT02920034
• Lead Sponsor: Heart Center Leipzig - University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-09-24
• Study First Submitted QC: 2016-09-28
• Study First Posted: 2016-09-30
• Primary Completion: 2018-09
• Study Completion: 2020-06
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-20
• Last Update Posted: 2021-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiofrequency main and branches	Radiofrequency denervation of renal arteries and branches	Renal sympathetic denervation of the main renal artery, its branches and accessories using the radiofrequency-based Spyral™ catheter (Medtronic, MN, USA)
Radiofrequency main renal artery	Radiofrequency denervation of the main renal arteries	Renal sympathetic denervation of the main renal artery using the radiofrequency-based Spyral™ catheter (Medtronic, MN, USA)
Ultrasound main renal artery	Ultrasound denervation of the main renal arteries	Renal sympathetic denervation of the main renal artery using the ultrasound-based Paradise™ catheter (ReCor, CA, USA)

Primary Outcome Measures

Name	Time	Method
Daytime blood pressure change	3 months after Intervention	Daytime blood pressure change in ambulatory blood pressure measurement

Secondary Outcome Measures

Name	Time	Method
General blood pressure change	24 months after Intervention	Change in 24 h average blood pressure change in ambulatory blood pressure measurement
Daytime blood pressure change	24 months after Intervention	Daytime blood pressure change in ambulatory blood pressure measurement
Exercise blood pressure change	3 months after Intervention	Change in exercise blood pressure on bicycle stress testing

Trial Locations

Locations (1)

Heart Center of the University Leipzig; 🇩🇪 Leipzig, Germany