Uncontrolled HypertensionNCT01996033
EnligHTN German Observational Study of Renal Denervation for Uncontrolled Hypertension
An observational study of Uncontrolled Hypertension, run by Abbott Medical Devices at 12 sites in Germany.
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 patients 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
- How many people
- 25 participants
- Where
- 12 sitesGermany
- Study dates
- Oct 2013to Jan 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: The patient population enrolled in this investigation will consist of males and females with uncontrolled hypertension who meet all inclusion criteria, and none of the exclusion criteria.
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 Systolic Blood Pressure (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), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE-I/ Angiotensin Receptor Blocker (ARB), Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs
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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Germany12 sites
Immanuelklinikum Bernau und Herzzentrum Brandenburg
Bernau bei Berlin, Brandenburg, 16321
Medizinische Einrichtungen der Universität Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225
Augusta-Krankenhaus Düsseldorf
Düsseldorf, 40472
Elisabeth-Krankenhaus Essen
Essen, North Rhine-Westphalia, 45138
Kliniken Oberallgäu gGmbH Klinik Immenstadt
Immenstadt im Allgäu, Bavaria, 87509
Universitätsklinikum Leipzig
Leipzig, Saxony, 04103
Klinikum Oldenburg gGmbH
Oldenburg, Lower Saxony, 26133
Klinikum Ernst von Bergmann
Potsdam, Brandenburg, 14467
Diakonie-Klinikum Schwäbisch Hall gGmbH
Schwäbisch Hall, 74523
Asklepios Schwalm-Eder-Kliniken GmbH
Schwalmstadt, Hesse, 34613
Kliniken Villingen-Schwenningen
Villingen-Schwenningen, Baden-Wurttemberg, 78052
Kardiologische Praxis Wuppertal
Wuppertal, North Rhine-Westphalia, 42103
About this study
Official title: This is a Post Market, Multi-center, Open Label, Observational Study. Approximately 500 Subjects With Uncontrolled Hypertension Will Undergo Renal Artery Ablation
The purpose of this observational study is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of patients with uncontrolled hypertension in clinical routine practice.
Read the detailed description
This is a post market, multi-center, open label, observational study. Approximately 500 subjects with uncontrolled hypertension will undergo renal artery ablation at approximately 40 investigational sites located in Germany and will be followed for 1 year post procedure.The expected duration of the investigation will be approximately 4 years.
- Conditions
- Uncontrolled Hypertension
- Keywords
- uncontrolled hypertension, Renal Denervation
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Reduction in Office Systolic Blood Pressure at 6 Months
Positive number indicates a reduction (improvement) in blood pressure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionJan 2017
- Study completionJan 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christoph K Naber, MD, Principal investigator, Elisabeth-Krankenhaus Essen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01996033
- Sponsor's protocol ID
- CV-12-064-GE-HT
- Status last verified
- Jan 2019
- First submitted
- 21 Nov 2013
- Last updated
- 4 Feb 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 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- This is a Post Market, Multi-center, Open Label, Observational Study. Approximately 500 Subjects With Uncontrolled Hypertension Will Undergo Renal Artery Ablation
- ClinicalTrials.gov ID
- NCT01996033
- Acronym / sponsor ID
- CV-12-064-GE-HT
- Conditions
- Uncontrolled Hypertension
- Keywords
- uncontrolled hypertension, Renal Denervation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 27 Nov 2013 (estimated)
- Results
- Posted 28 Sep 2018
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 patients with uncontrolled hypertension in clinical routine practice.
Detailed description
This is a post market, multi-center, open label, observational study. Approximately 500 subjects with uncontrolled hypertension will undergo renal artery ablation at approximately 40 investigational sites located in Germany and will be followed for 1 year post procedure.The expected duration of the investigation will be approximately 4 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient population enrolled in this investigation will consist of males and females with uncontrolled hypertension who meet all inclusion criteria, and none of the exclusion criteria.
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 Systolic Blood Pressure (SBP) ≥ 140 mmHg
Key exclusion criteria (6 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.
Primary outcome
Mean Reduction in Office Systolic Blood Pressure at 6 Months
Time frame: 6 months
Positive number indicates a reduction (improvement) in blood pressure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 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.
Christoph K Naber, MD principal investigator
Elisabeth-Krankenhaus Essen, Germany
12 sites in 1 country: 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 12 sites 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 6 inclusion and 6 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 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
Yes. Results are posted in the registry (first posted 28 Sep 2018). 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 Reduction in Office Systolic Blood Pressure at 6 Months (time frame: 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 4 Feb 2019.