Primary HypertensionPhase 3Iberis-HTNNCT02901704
Renal Denervation by Iberis MultiElectrode Renal Denervation System in Patients With Primary Hypertension
A Phase 3 study testing Renal Denervation System (AngioCare) in people with Primary Hypertension, run by Shanghai AngioCare Medical.
Trial summary
The purpose of Iberis-HTN trial is to evaluate the safety and effectiveness of renal denervation in subjects with primary hypertension by using Iberis multielectrode renal denervation system Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Hypertension
- What is being tested?
- Renal Denervation System (AngioCare)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2018
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 65 years
- Primary Hypertension
- Stable medication regimen including 3 antihypertensive medications of different classes, including a diuretic (with no changes for a minimum of 4 weeks prior to screening) and 1) Office SBP ≥150 and ≤180 mmHg, and DBP ≥90 , 2) average 24-hour ambulatory systolic blood pressue and/or DBP ≥135 and ≤170 mmHg
- Main renal arteries with ≥3 mm diameter or with ≥20 mm treatable length (by visual estimation)
- Written informed consent
Who cannot join
- Clinical Exclusion Criteria:
- Known secondary hypertension
- Type 1 diabetes mellitus
- Has an implantable cardioverter defibrillator (ICD) or pacemaker
- Myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within 6 months of the screening period
- Has hemodynamically significant valvular heart disease
Show all 15Show fewer
- Pregnant, nursing, or planning to be pregnant
- Any serious medical condition that may adversely affect the safety of the participant or the study
- Currently enrolled in another investigational drug or device trial
- 2.Angiographic Exclusion Criteria
- Renal artery stenosis (≥50%) or renal artery aneurysm in either renal artery
- History of prior renal artery intervention including balloon angioplasty or stenting
- Multiple renal arteries where the main renal artery is estimated to supply <75% of the kidney
- Main renal arteries with <3 mm diameter or with <20 mm treatable length (by visual estimation)
- Renal artery abnormalities
About this study
Official title: A Prospective, Multi-centers, Randomized,Controlled, Blinded,Superiority Trial of Renal Denervation Using Iberis MultiElectrode Renal Denervation System for the Treatment of Primary Hypertension.
The purpose of Iberis-HTN trial is to evaluate the safety and effectiveness of renal denervation in subjects with primary hypertension by using Iberis multielectrode renal denervation system
Read the detailed description
The purpose was to evaluate 3-month outcomes of RDN for the treatment of primary hypertension in Chinese patients.In a prospective, multi-center study, 216 Chinese patients with primary hypertension would be recruited to undergo RDN by Iberis Multielectrode denervation system. The primary effectiveness endpoint wasReduction in average 24-hour ambulatory systolic blood pressue at 3 months follow-up.
- Conditions
- Primary Hypertension
- Being tested
- Renal Denervation System (AngioCare), Sham procedure
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal Denervation System (AngioCare)Device
After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
Sham procedureProcedure or surgery
After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 10 minutes prior to introducer sheath removal.
| Study group | Role | What they receive |
|---|---|---|
| renal denervation | Experimental | Iberis Multielectrode Renal Denervation System (AngioCare) Receives: Device: Renal Denervation System (AngioCare) |
| Sham procedure | Sham comparator | Renal anigography Receives: Procedure: Sham procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in average 24-hour ambulatory systolic blood pressue at 3 months follow-up
Measured: 3 months
Secondary outcomes (3)
Reduction in average 24-hour ambulatory systolic blood pressue at 6 months
Measured: 6 months
Change in office systolic blood pressure
Measured: 1 month,3 months,6 months and 12 months
Device or procedure related acute adverse events
Measured: 1 month,3 months,6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startDec 2016
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai AngioCare Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901704
- Sponsor's protocol ID
- AT201601
- Acronym
- Iberis-HTN
- Status last verified
- Sep 2016
- First submitted
- 12 Sep 2016
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Jiang X, Mahfoud F, Li W, Dong H, Yu J, Yu S, Chen X, Wang P, Li Z, Lauder L, Wang Z, Ji Z, Dong Y, Han B, Zhu Z, Chen Y, Xu J, Zhao X, Fan W, Xie W, Hubbard B, Hu X, Kario K, Gao R. Efficacy and Safety of Catheter-Based Radiofrequency Renal Denervation in Chinese Patients With Uncontrolled Hypertension: The Randomized, Sham-Controlled, Multi-Center Iberis-HTN Trial. Circulation. 2024 Nov 12;150(20):1588-1598. doi: 10.1161/CIRCULATIONAHA.124.069215. Epub 2024 Sep 4.
PubMed 39229700
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-centers, Randomized,Controlled, Blinded,Superiority Trial of Renal Denervation Using Iberis MultiElectrode Renal Denervation System for the Treatment of Primary Hypertension.
- ClinicalTrials.gov ID
- NCT02901704
- Acronym / sponsor ID
- Iberis-HTN / AT201601
- Conditions
- Primary Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Shanghai AngioCare MedicalIndustry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 15 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.
The purpose of Iberis-HTN trial is to evaluate the safety and effectiveness of renal denervation in subjects with primary hypertension by using Iberis multielectrode renal denervation system
Detailed description
The purpose was to evaluate 3-month outcomes of RDN for the treatment of primary hypertension in Chinese patients.In a prospective, multi-center study, 216 Chinese patients with primary hypertension would be recruited to undergo RDN by Iberis Multielectrode denervation system. The primary effectiveness endpoint wasReduction in average 24-hour ambulatory systolic blood pressue at 3 months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| renal denervation | Experimental | Device: Renal Denervation System (AngioCare)Iberis Multielectrode Renal Denervation System (AngioCare) |
| Sham procedure | Sham comparator | Procedure: Sham procedureRenal anigography |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 - 65 years
- Primary Hypertension
- Stable medication regimen including 3 antihypertensive medications of different classes, including a diuretic (with no changes for a minimum of 4 weeks prior to screening) and 1) Office SBP ≥150 and ≤180 mmHg, and DBP ≥90 , 2) average 24-hour ambulatory systolic blood pressue and/or DBP ≥135 and ≤170 mmHg
- Main renal arteries with ≥3 mm diameter or with ≥20 mm treatable length (by visual estimation)
- Written informed consent
Key exclusion criteria (15 listed)
- Known secondary hypertension
- Type 1 diabetes mellitus
- Has an implantable cardioverter defibrillator (ICD) or pacemaker
- Myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within 6 months of the screening period
- Has hemodynamically significant valvular heart disease
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 |
|---|---|---|
| Renal Denervation System (AngioCare)After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization. | Device | renal denervation |
| Sham procedureAfter a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 10 minutes prior to introducer sheath removal. | Procedure or surgery | Sham procedure |
Primary outcome
Reduction in average 24-hour ambulatory systolic blood pressue at 3 months follow-up
Time frame: 3 months
3 secondary outcomes
Reduction in average 24-hour ambulatory systolic blood pressue at 6 months
Time frame: 6 months
Change in office systolic blood pressure
Time frame: 1 month,3 months,6 months and 12 months
Device or procedure related acute adverse events
Time frame: 1 month,3 months,6 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
- Derived from this study: PubMed 39229700Jiang X, Mahfoud F, Li W, Dong H, Yu J, Yu S, Chen X, Wang P, Li Z, Lauder L, Wang Z, Ji Z, Dong Y, Han B, Zhu Z, Chen Y, Xu J, Zhao X, Fan W, Xie W, Hubbard B, Hu X, Kario K, Gao R. Efficacy and Safety of Catheter-Based Radiofrequency Renal Denervation in Chinese Patients With Uncontrolled Hypertension: The Randomized, Sham-Controlled, Multi-Center Iberis-HTN Trial. Circulation. 2024 Nov 12;150(20):1588-1598. doi: 10.1161/CIRCULATIONAHA.124.069215. Epub 2024 Sep 4.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Renal Denervation System (AngioCare) in people with Primary Hypertension, run by Shanghai AngioCare Medical.
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 5 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Reduction in average 24-hour ambulatory systolic blood pressue at 3 months follow-up (time frame: 3 months). 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 NCT02901704, which also lists 1 linked publication.
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 15 Sep 2016.