Resistant HypertensionIberisNCT02295683
Renal Sympathetic Denervation by Iberis System in Patients With Uncontrolled Hypertension - Iberis-HTN Registry
An observational study of Resistant Hypertension, run by Terumo Europe N.V. at 2 sites in 2 countries.
Trial summary
The purpose of this study is to document safety and efficacy of renal sympathetic denervation treatment in subjects with uncontrolled hypertension by using Iberis renal denervation system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resistant Hypertension
- What is being tested?
- Renal Denervation
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2014to 4 Sep 2017
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with uncontrolled hypertension entitled to receive renal sympathetic denervation treatment per routine hospital practice and according to relevant international, or country specific guidelines
Who may be able to join
- Age ≥18 years or minimum age as required by local regulations.
- Patient has been thoroughly informed about this registry and signed Informed Consent Form.
- Patient with true resistant hypertension defined as:
- Office systolic BP higher than 160 or 150mmHg in case of type 2 diabetes
- Ambulatory BP with average BP>130mmHg or mean daytime>135mmHg in more than 70% of the measurements.
- Patients should be on stable hypertension therapy for at least 8 weeks before procedure, including spironolactone if they are supposed to be respondent as indicated by the specialized center/excellence unit on hypertension.
Who cannot join
- Previous renal artery intervention (balloon angioplasty or stenting).
- Evidence of renal artery atherosclerosis (defined as a renal artery stenosis >50%).
- Main renal arteries of less than 4mm diameter or less than 20mm in length.
- Presence of multiple main renal arteries in either kidney.
- Estimated glomerular filtration rate <45ml/min per 1,73m2
- Recent myocardial infarction, unstable angina pectoris or cerebrovascular accident within the past 3-6 months.
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- False resistant hypertension (pseudo resistance) by using 24h ambulatory BP monitoring (ABPM).
- Secondary arterial hypertension.
- Pregnancy.
- There is another pathological process with well-known life expectancy of less than 5 years.
- Patient unable to do correct FU.
- Unable to take correct ambulatory BP.
- Primary hyperaldosteronism.
- Known lack of adherence to medical treatment.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Renal Sympathetic Denervation by Iberis System in Patients With Uncontrolled Hypertension - IBERIS - HTN Registry
The purpose of this study is to document safety and efficacy of renal sympathetic denervation treatment in subjects with uncontrolled hypertension by using Iberis renal denervation system.
Read the detailed description
This study is a prospective, multi-center, single-arm, non-interventional and open-label registry to collect descriptive data from patients who receive renal sympathetic denervation treatment in accordance with routine hospital practice using Iberis system.
This registry will collect data prospectively from patients that receive renal sympathetic denervation treatment with use of Iberis renal denervation system and treatment will be applied according to the routine hospital practice. No additional tests are required specific to this registry. The registry will serve as a tool to collect clinical data in order to expand the knowledge base of safety, efficacy and functionality of the Iberis system in patients with resistant hypertension.
A minimum of 30 patients will be enrolled in Europe
- Conditions
- Resistant Hypertension
- Being tested
- Renal Denervation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal DenervationDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure (BP) Measurements
Office BP; Ambulatory BP; Home BP
Measured: Up to 5 year FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startNov 2014
- Primary completion30 Nov 2016
- Study completion4 Sep 2017
Why it stopped: The study was prematurely discontinued due to the low rate of enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Terumo Europe N.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- José Ramon Rumoroso, Dr., Principal investigator, Hospital GaldakaoPalop López, Dr., Principal investigator, Hospital San Juan AlicanteMauri, Dr., Principal investigator, Germans Trias i Pujol HospitalPerez, Dr., Principal investigator, Hospital de LéonGarcia, Dr., Principal investigator, Hospital MonteprincipeGoicolea, Dr., Principal investigator, Hospital Puerta de HierroGoran Stankovic, Dr., Principal investigator, Clinical Center of Serbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295683
- Sponsor's protocol ID
- T124E2
- Acronym
- Iberis
- Status last verified
- Oct 2019
- First submitted
- 17 Nov 2014
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Sympathetic Denervation by Iberis System in Patients With Uncontrolled Hypertension - IBERIS - HTN Registry
- ClinicalTrials.gov ID
- NCT02295683
- Acronym / sponsor ID
- Iberis / T124E2
- Conditions
- Resistant Hypertension
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was prematurely discontinued due to the low rate of enrollment.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Terumo Europe N.V.Industry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 4 Sep 2017 (actual)
- First posted
- 20 Nov 2014 (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 this study is to document safety and efficacy of renal sympathetic denervation treatment in subjects with uncontrolled hypertension by using Iberis renal denervation system.
Detailed description
This study is a prospective, multi-center, single-arm, non-interventional and open-label registry to collect descriptive data from patients who receive renal sympathetic denervation treatment in accordance with routine hospital practice using Iberis system.
This registry will collect data prospectively from patients that receive renal sympathetic denervation treatment with use of Iberis renal denervation system and treatment will be applied according to the routine hospital practice. No additional tests are required specific to this registry. The registry will serve as a tool to collect clinical data in order to expand the knowledge base of safety, efficacy and functionality of the Iberis system in patients with resistant hypertension.
A minimum of 30 patients will be enrolled in Europe
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with uncontrolled hypertension entitled to receive renal sympathetic denervation treatment per routine hospital practice and according to relevant international, or country specific guidelines
Key inclusion criteria (6 listed)
- Age ≥18 years or minimum age as required by local regulations.
- Patient has been thoroughly informed about this registry and signed Informed Consent Form.
- Patient with true resistant hypertension defined as:
- Patients should be on stable hypertension therapy for at least 8 weeks before procedure, including spironolactone if they are supposed to be respondent as indicated by the specialized center/excellence unit on hypertension.
Key exclusion criteria (14 listed)
- Previous renal artery intervention (balloon angioplasty or stenting).
- Evidence of renal artery atherosclerosis (defined as a renal artery stenosis >50%).
- Main renal arteries of less than 4mm diameter or less than 20mm in length.
- Presence of multiple main renal arteries in either kidney.
- Estimated glomerular filtration rate <45ml/min per 1,73m2
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 | Device | – |
Primary outcome
Blood Pressure (BP) Measurements
Time frame: Up to 5 year FU
Office BP; Ambulatory BP; Home BP
Results and safety
The study was stopped early (reason given: The study was prematurely discontinued due to the low rate of enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
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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.
José Ramon Rumoroso, Dr. principal investigator
Hospital Galdakao
Palop López, Dr. principal investigator
Hospital San Juan Alicante
Mauri, Dr. principal investigator
Germans Trias i Pujol Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resistant Hypertension, run by Terumo Europe N.V. at 2 sites in 2 countries.
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 6 inclusion and 14 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: stopped early, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Serbia, Spain. 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 was stopped early (reason given: The study was prematurely discontinued due to the low rate of enrollment.). 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?
Blood Pressure (BP) Measurements (time frame: Up to 5 year FU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2019.