Uncontrolled HypertensionNCT02006758
Observational Study of the EnligHTN Renal Denervation System in Europe
An observational study of Uncontrolled Hypertension, run by Abbott Medical Devices at 13 sites in 6 countries.
Trial summary
The purpose of this observational study is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of participants with uncontrolled hypertension in clinical routine practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uncontrolled Hypertension
- What is being tested?
- EnligHTN™ Renal Denervation System
- Type of treatment
- Medical device
- How many people
- 68 participants
- Where
- 13 sitesin 6 countries
- Study dates
- Nov 2013to May 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Subject is planned to undergo a renal denervation procedure for the treatment of hypertension
- Subject is ≥18 years of age at time of consent
- Subject must be able and willing to provide written informed consent
- Subject must be able and willing to comply with the required follow-up schedule
- Subject has office SBP ≥ 140 mmHg
- Subject has established hypertension (diagnosed ≥12 months prior to baseline) and is on a guideline based drug regimen at a stable (≥ 14 days) and a fully tolerated dose consisting of ≥3 anti-hypertensive medications (including 1 diuretic)
Who cannot join
- Subject has known significant renovascular abnormalities such as renal artery stenosis > 30%
- Subject has undergone prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent grafts
- Subject has a history of hemodynamically significant valvular heart disease
- Subject has blood clotting abnormalities
- Subject life expectancy is < 12 months, as determined by the Study Investigator
- Subject is participating in another clinical study which has the potential to impact his/her hypertension management (pharmaceutical/ device/ homeopathic)
Show all 11Show fewer
- Subject is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods
- Subject has active systemic infection
- Subject has known renal arteries with diameter(s) < 4 mm
- Subject has an estimated GFR <45 mL/min per 1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula
- Subject had a renal transplant or is awaiting a renal transplant
Trial locations and contacts
13 sites in 6 countries.
13 sites in 6 countries
Spain5 sites
Hopspital Infanta Cristina
Badajoz, 06010
Hospital Juan Ramon Jimenez
Huelva, Andalusia, 21005
Clinica Universitaria de Navarra
Pamplona, Navarre, 31008
Hospital Universitari i Politecnic La Fe
Valencia, 46206
Hospital Xeral-Cies de Vigo
Vigo, 36204
Italy4 sites
Dr. Gianluigi Patelli
Alzano Lombardo, Lombardy, 24068
Instituto Clinico Citta Studi
Milan, Lombardy, 20131
Clinica San Gaudenzio
Novara, Peimonte, 28100
Policlinico San Marco
Osio Sotto, Lombardy, 24040
United Kingdom1 site
Craigavon Area Hospital
Portadown, Nirelnd, BT63 5QQ
About this study
Official title: EnligHTN European Observational Study
The purpose of this observational study is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of participants with uncontrolled hypertension in clinical routine practice.
Read the detailed description
The EnligHTN European Observational study is designed to collect more data, critical to the benefit of the therapy, within a clinical routine setting.
- Conditions
- Uncontrolled Hypertension
- Being tested
- EnligHTN™ Renal Denervation System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnligHTN™ Renal Denervation SystemDevice
The EnligHTN™ Renal Denervation System is designed to deliver radiofrequency (RF) energy to the renal nerves to achieve targeted denervation. The system consists of the EnligHTN™ RF Ablation Generator (generator), the EnligHTN™ Renal Artery Ablation Catheter (ablation catheter), and the EnligHTN™ Guiding Catheter (optional).
| Study group | Role | What they receive |
|---|---|---|
| Uncontrolled hypertension patients | The study will enroll 500 patients planned to undergo a renal denervation procedure (with the 'EnligHTN™ Renal Denervation System') for the treatment of their uncontrolled hypertension. Receives: Device: EnligHTN™ Renal Denervation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Office Systolic Blood Pressure at 6 Months
Measured: Baseline and 6 months
Secondary outcomes (18)
Assessment of Peri-procedural Adverse Events up Until 30 Days Post Procedure
Measured: 30 days
Mean Change in Office Systolic Blood Pressure at 1 Month
Measured: Baseline and 1 month
Mean Change in Office Diastolic Blood Pressure at 1 Month
Measured: Baseline and 1 month
Mean Change in Ambulatory Systolic Blood Pressure at 1 Month
Measured: Baseline and 1 month
Mean Change in Ambulatory Diastolic Blood Pressure at 1 Month
Measured: Baseline and 1 month
Percentage of Subjects Achieving Office Systolic Blood Pressure < 140 mmHg at 1 Month
Measured: 1 month
Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 6 Months
Measured: Baseline and 6 months
Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 12 Months
Measured: Baseline and 12 months
Renovascular Safety at 6 Months (Renal Artery Stenosis)
Assessment of renovascular safety as measured by new renal artery stenosis or aneurysm at the site of ablation.
Measured: 6 months
Mean Change in Office Systolic Blood Pressure at 12 Months
Measured: Baseline and 12 months
Mean Change in Office Diastolic Blood Pressure at 6 Months
Measured: Baseline and 6 months
Mean Change in Office Diastolic Blood Pressure at 12 Months
Measured: Baseline and 12 months
Mean Change in Ambulatory Systolic Blood Pressure at 6 Months
Measured: Baseline and 6 months
Mean Change in Ambulatory Systolic Blood Pressure at 12 Months
Measured: Baseline and 12 months
Mean Change in Ambulatory Diastolic Blood Pressure at 6 Months
Measured: Baseline and 6 months
Mean Change in Ambulatory Diastolic Blood Pressure at 12 Months
Measured: Baseline and 12 months
Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 6 Months
Measured: 6 months
Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 12 Months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Uncontrolled HypertensionStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- José Diaz, MD, Principal investigator, Hospital Juan Ramon Jimenez, Huelva, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006758
- Sponsor's protocol ID
- CV-12-064-EU-HT
- Status last verified
- Aug 2019
- First submitted
- 5 Dec 2013
- Last updated
- 16 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EnligHTN European Observational Study
- ClinicalTrials.gov ID
- NCT02006758
- Acronym / sponsor ID
- CV-12-064-EU-HT
- Conditions
- Uncontrolled Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 10 Dec 2013 (estimated)
- Results
- Posted 16 Oct 2019
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 observational study is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of participants with uncontrolled hypertension in clinical routine practice.
Detailed description
The EnligHTN European Observational study is designed to collect more data, critical to the benefit of the therapy, within a clinical routine setting.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Uncontrolled hypertension patients | – | Device: EnligHTN™ Renal Denervation SystemThe study will enroll 500 patients planned to undergo a renal denervation procedure (with the 'EnligHTN™ Renal Denervation System') for the treatment of their uncontrolled hypertension. |
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
Key inclusion criteria (6 listed)
- Subject is planned to undergo a renal denervation procedure for the treatment of hypertension
- Subject is ≥18 years of age at time of consent
- Subject must be able and willing to provide written informed consent
- Subject must be able and willing to comply with the required follow-up schedule
- Subject has office SBP ≥ 140 mmHg
Key exclusion criteria (11 listed)
- Subject has known significant renovascular abnormalities such as renal artery stenosis > 30%
- Subject has undergone prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent grafts
- Subject has a history of hemodynamically significant valvular heart disease
- Subject has blood clotting abnormalities
- Subject life expectancy is < 12 months, as determined by the Study Investigator
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 |
|---|---|---|
| EnligHTN™ Renal Denervation SystemThe EnligHTN™ Renal Denervation System is designed to deliver radiofrequency (RF) energy to the renal nerves to achieve targeted denervation. The system consists of the EnligHTN™ RF Ablation Generator (generator), the EnligHTN™ Renal Artery Ablation Catheter (ablation catheter), and the EnligHTN™ Guiding Catheter (optional). | Device | Uncontrolled hypertension patients |
Primary outcome
Mean Change in Office Systolic Blood Pressure at 6 Months
Time frame: Baseline and 6 months
18 secondary outcomes
Assessment of Peri-procedural Adverse Events up Until 30 Days Post Procedure
Time frame: 30 days
Mean Change in Office Systolic Blood Pressure at 1 Month
Time frame: Baseline and 1 month
Mean Change in Office Diastolic Blood Pressure at 1 Month
Time frame: Baseline and 1 month
Mean Change in Ambulatory Systolic Blood Pressure at 1 Month
Time frame: Baseline and 1 month
Mean Change in Ambulatory Diastolic Blood Pressure at 1 Month
Time frame: Baseline and 1 month
Percentage of Subjects Achieving Office Systolic Blood Pressure < 140 mmHg at 1 Month
Time frame: 1 month
Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 6 Months
Time frame: Baseline and 6 months
Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 12 Months
Time frame: Baseline and 12 months
Renovascular Safety at 6 Months (Renal Artery Stenosis)
Time frame: 6 months
Mean Change in Office Systolic Blood Pressure at 12 Months
Time frame: Baseline and 12 months
Mean Change in Office Diastolic Blood Pressure at 6 Months
Time frame: Baseline and 6 months
Mean Change in Office Diastolic Blood Pressure at 12 Months
Time frame: Baseline and 12 months
Mean Change in Ambulatory Systolic Blood Pressure at 6 Months
Time frame: Baseline and 6 months
Mean Change in Ambulatory Systolic Blood Pressure at 12 Months
Time frame: Baseline and 12 months
Mean Change in Ambulatory Diastolic Blood Pressure at 6 Months
Time frame: Baseline and 6 months
Mean Change in Ambulatory Diastolic Blood Pressure at 12 Months
Time frame: Baseline and 12 months
Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 6 Months
Time frame: 6 months
Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 12 Months
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 Diaz, MD principal investigator
Hospital Juan Ramon Jimenez, Huelva, Spain
13 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uncontrolled Hypertension, run by Abbott Medical Devices at 13 sites in 6 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 11 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 16 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 13 sites in Spain, Italy, Belgium, Estonia, Portugal and 1 more country. 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?
Yes. Results are posted in the registry (first posted 16 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change in Office Systolic Blood Pressure at 6 Months (time frame: Baseline and 6 months). 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 16 Oct 2019.