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Completed

NCT Number: NCT02920034

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

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

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Key information

Conditions

Therapy Resistant Hypertension

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heart Center of the University Leipzig

Leipzig, 04289, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

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)

Primary outcomes

  1. Daytime blood pressure change

    Time frame: 3 months after Intervention

    Daytime blood pressure change in ambulatory blood pressure measurement

Secondary outcomes

  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. Daytime blood pressure change

    Time frame: 24 months after Intervention

    Daytime blood pressure change in ambulatory blood pressure measurement

  6. General blood pressure change

    Time frame: 12 months after Intervention

    Change in 24 h average blood pressure change in ambulatory blood pressure measurement

  7. General blood pressure change

    Time frame: 24 months after Intervention

    Change in 24 h average blood pressure change in ambulatory blood pressure measurement

  8. Exercise blood pressure change

    Time frame: 3 months after Intervention

    Change in exercise blood pressure on bicycle stress testing

Sponsors and collaborators

Lead sponsor

Heart Center Leipzig - University Hospital

Other

Registry information

Official study title

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

Acronym: RADIOSOUND

Important dates

Study start
2015
Primary completion
2018
Study completion
2020
First posted
Sep 30, 2016
Registry last updated
May 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.