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

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

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

Study Overview

• Status: Completed
• Conditions: Therapy Resistant Hypertension
• Intervention / Treatment: Device: Radiofrequency denervation of the main renal arteries; Device: Radiofrequency denervation of renal arteries and branches; Device: Ultrasound denervation of the main 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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Leipzig, Germany, 04289
    • Heart Center of the University Leipzig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Radiofrequency main renal artery; 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; Catheter based renal sympathetic denervation of the main renal arteries using the Spyral™ Catheter (Medtronic, MN, USA)
Experimental: Radiofrequency main and branches; 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; Catheter based renal sympathetic denervation of the main renal arteries and its branches using the Spyral™ Catheter (Medtronic, MN, USA)
Experimental: Ultrasound main renal artery; 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; Catheter based renal sympathetic denervation of the main renal arteries using the Paradise™ Catheter (ReCor Medical, CA, USA)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Heart Center Leipzig - University Hospital
• Investigators: Principal Investigator: Philipp C Lurz, MD, PhD, Heart Center of the University Leipzig

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: September 24, 2016
• First Submitted That Met QC Criteria: September 28, 2016
• First Posted (Estimate): September 30, 2016

Study Record Updates

• Last Update Posted (Actual): May 24, 2021
• Last Update Submitted That Met QC Criteria: May 20, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: Radiosound 1.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED