Therapy Resistant HypertensionRADIOSOUNDNCT02920034
Randomized Comparison of Ultrasound Versus Radiofrequency Denervation in Patients With Therapy Resistant Hypertension
A study testing Radiofrequency denervation of the main renal arteries, Radiofrequency denervation of renal arteries and branches and Ultrasound denervation of the main renal arteries in people with Therapy Resistant Hypertension, run by Heart Center Leipzig - University Hospital at 1 site in Germany.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Therapy Resistant Hypertension
- What is being tested?
- Radiofrequency denervation of the main renal arteries, Radiofrequency denervation of renal arteries and branches and Ultrasound denervation of the main renal arteries
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2015to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Therapy Resistant Hypertension
- Being tested
- Radiofrequency denervation of the main renal arteries, Radiofrequency denervation of renal arteries and branches, Ultrasound denervation of the main renal arteries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency denervation of the main renal arteriesDevice
Catheter based renal sympathetic denervation of the main renal arteries using the Spyral™ Catheter (Medtronic, MN, USA)
Radiofrequency denervation of renal arteries and branchesDevice
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 arteriesDevice
Catheter based renal sympathetic denervation of the main renal arteries using the Paradise™ Catheter (ReCor Medical, CA, USA)
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency main renal artery | Active comparator | Renal sympathetic denervation of the main renal artery using the radiofrequency-based Spyral™ catheter (Medtronic, MN, USA) Receives: Device: Radiofrequency denervation of the main renal arteries |
| Radiofrequency main and branches | Experimental | Renal sympathetic denervation of the main renal artery, its branches and accessories using the radiofrequency-based Spyral™ catheter (Medtronic, MN, USA) Receives: Device: Radiofrequency denervation of renal arteries and branches |
| Ultrasound main renal artery | Experimental | Renal sympathetic denervation of the main renal artery using the ultrasound-based Paradise™ catheter (ReCor, CA, USA) Receives: Device: Ultrasound denervation of the main renal arteries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daytime blood pressure change
Daytime blood pressure change in ambulatory blood pressure measurement
Measured: 3 months after Intervention
Secondary outcomes (8)
General blood pressure change
Change in 24 h average blood pressure change in ambulatory blood pressure measurement
Measured: 3 months after Intervention
Daytime blood pressure change
Daytime blood pressure change in ambulatory blood pressure measurement
Measured: 6 months after Intervention
General blood pressure change
Change in 24 h average blood pressure change in ambulatory blood pressure measurement
Measured: 6 months after Intervention
Daytime blood pressure change
Daytime blood pressure change in ambulatory blood pressure measurement
Measured: 12 months after Intervention
Daytime blood pressure change
Daytime blood pressure change in ambulatory blood pressure measurement
Measured: 24 months after Intervention
General blood pressure change
Change in 24 h average blood pressure change in ambulatory blood pressure measurement
Measured: 12 months after Intervention
General blood pressure change
Change in 24 h average blood pressure change in ambulatory blood pressure measurement
Measured: 24 months after Intervention
Exercise blood pressure change
Change in exercise blood pressure on bicycle stress testing
Measured: 3 months after Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startJun 2015
- Primary completionSep 2018
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Therapy Resistant HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart Center Leipzig - University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philipp Lurz, Heart Center Leipzig - University Hospital
- Investigators
- Philipp C Lurz, MD, PhD, Principal investigator, Heart Center of the University Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920034
- Sponsor's protocol ID
- Radiosound 1.1
- Acronym
- RADIOSOUND
- Status last verified
- May 2021
- First submitted
- 24 Sep 2016
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Fengler K, Rommel KP, Kriese W, Blazek S, Besler C, von Roeder M, Desch S, Thiele H, Lurz P. 6- and 12-Month Follow-Up From a Randomized Clinical Trial of Ultrasound vs Radiofrequency Renal Denervation (RADIOSOUND-HTN). JACC Cardiovasc Interv. 2023 Feb 13;16(3):367-369. doi: 10.1016/j.jcin.2022.10.058. No abstract available.
PubMed 36792266Fengler 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.
PubMed 31203726Fengler 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.
PubMed 30586691
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02920034
- Acronym / sponsor ID
- RADIOSOUND / Radiosound 1.1
- Conditions
- Therapy Resistant Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Heart Center Leipzig - University HospitalUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 30 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency main renal artery | Active comparator | Device: Radiofrequency denervation of the main renal arteriesRenal sympathetic denervation of the main renal artery using the radiofrequency-based Spyral™ catheter (Medtronic, MN, USA) |
| Radiofrequency main and branches | Experimental | Device: Radiofrequency denervation of renal arteries and branchesRenal sympathetic denervation of the main renal artery, its branches and accessories using the radiofrequency-based Spyral™ catheter (Medtronic, MN, USA) |
| Ultrasound main renal artery | Experimental | Device: Ultrasound denervation of the main renal arteriesRenal sympathetic denervation of the main renal artery using the ultrasound-based Paradise™ catheter (ReCor, CA, USA) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency denervation of the main renal arteriesCatheter based renal sympathetic denervation of the main renal arteries using the Spyral™ Catheter (Medtronic, MN, USA) | Device | Radiofrequency main renal artery |
| Radiofrequency denervation of renal arteries and branchesCatheter based renal sympathetic denervation of the main renal arteries and its branches using the Spyral™ Catheter (Medtronic, MN, USA) | Device | Radiofrequency main and branches |
| Ultrasound denervation of the main renal arteriesCatheter based renal sympathetic denervation of the main renal arteries using the Paradise™ Catheter (ReCor Medical, CA, USA) | Device | Ultrasound main renal artery |
Primary outcome
Daytime blood pressure change
Time frame: 3 months after Intervention
Daytime blood pressure change in ambulatory blood pressure measurement
8 secondary outcomes
General blood pressure change
Time frame: 3 months after Intervention
Daytime blood pressure change
Time frame: 6 months after Intervention
General blood pressure change
Time frame: 6 months after Intervention
Daytime blood pressure change
Time frame: 12 months after Intervention
Daytime blood pressure change
Time frame: 24 months after Intervention
General blood pressure change
Time frame: 12 months after Intervention
General blood pressure change
Time frame: 24 months after Intervention
Exercise blood pressure change
Time frame: 3 months after Intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Derived from this study: PubMed 36792266Fengler K, Rommel KP, Kriese W, Blazek S, Besler C, von Roeder M, Desch S, Thiele H, Lurz P. 6- and 12-Month Follow-Up From a Randomized Clinical Trial of Ultrasound vs Radiofrequency Renal Denervation (RADIOSOUND-HTN). JACC Cardiovasc Interv. 2023 Feb 13;16(3):367-369. doi: 10.1016/j.jcin.2022.10.058. No abstract available.
- Derived from this study: PubMed 31203726Fengler 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.
- Derived from this study: PubMed 30586691Fengler 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.
- Individual participant dataSharing planned: Undecided
Related trials for Therapy Resistant Hypertension
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
RecruitingPhase 2
Study of TX000045 in Participants With Pulmonary Hypertension Due to Interstitial Lung Disease
Hypertension, Pulmonary, Lung Diseases, Interstitial
Enrolling by invitationObservational study
Heart Rate Variability and Medication Adherence in Resistant Hypertension
Resistant Hypertension, Medication Adherence
RecruitingPhase 4
Antihypertensive Mechanisms of Minocycline in Resistant Hypertension
Hypertension, Resistant to Conventional Therapy
Not yet recruiting
The RESPLASH Study
Resistant Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philipp C Lurz, MD, PhD principal investigator
Heart Center of the University Leipzig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency denervation of the main renal arteries, Radiofrequency denervation of renal arteries and branches and Ultrasound denervation of the main renal arteries in people with Therapy Resistant Hypertension, run by Heart Center Leipzig - University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daytime blood pressure change (time frame: 3 months after Intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02920034, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2021.