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Trial record 1 of 1 for:    RADIOSOUND renal denervation
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Randomized Comparison of Ultrasound Versus Radiofrequency Denervation in Patients With Therapy Resistant Hypertension (RADIOSOUND)

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ClinicalTrials.gov Identifier: NCT02920034
Recruitment Status : Active, not recruiting
First Posted : September 30, 2016
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Philipp Lurz, University of Leipzig

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

Condition or disease Intervention/treatment Phase
Therapy Resistant Hypertension Device: Radiofrequency denervation of the main renal arteries Device: Radiofrequency denervation of renal arteries and branches Device: Ultrasound denervation of the main renal arteries Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Ultrasound Based Versus Radiofrequency Based Catheter Ablation Techniques in Patients With Therapy Resistant Arterial Hypertension With Large Renal Arteries
Actual Study Start Date : June 2015
Actual Primary Completion Date : September 2018
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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)




Primary Outcome Measures :
  1. Daytime blood pressure change [ Time Frame: 3 months after Intervention ]
    Daytime blood pressure change in ambulatory blood pressure measurement


Secondary Outcome Measures :
  1. General blood pressure change [ Time Frame: 3 months after Intervention ]
    Change in 24 h average blood pressure change in ambulatory blood pressure measurement

  2. Daytime blood pressure change [ Time Frame: 6 months after Intervention ]
    Daytime blood pressure change in ambulatory blood pressure measurement

  3. General blood pressure change [ Time Frame: 6 months after Intervention ]
    Change in 24 h average blood pressure change in ambulatory blood pressure measurement

  4. Daytime blood pressure change [ Time Frame: 12 months after Intervention ]
    Daytime blood pressure change in ambulatory blood pressure measurement

  5. General blood pressure change [ Time Frame: 12 months after Intervention ]
    Change in 24 h average blood pressure change in ambulatory blood pressure measurement

  6. Exercise blood pressure change [ Time Frame: 3 months after Intervention ]
    Change in exercise blood pressure on bicycle stress testing



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02920034


Locations
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Germany
Heart Center of the University Leipzig
Leipzig, Germany, 04289
Sponsors and Collaborators
University of Leipzig
Investigators
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Principal Investigator: Philipp C Lurz, MD, PhD Heart Center of the University Leipzig

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Philipp Lurz, PD Dr. Dr. med. Philipp Lurz, University of Leipzig
ClinicalTrials.gov Identifier: NCT02920034    
Other Study ID Numbers: Radiosound 1.1
First Posted: September 30, 2016    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases