HypertensionPhase 1/2NCT01888315
Influence of Catheter-based Renal Denervation in Diseases With Increased Sympathetic Activity
A Phase 1/2 study testing Renal denervation with Symplicity Flex Medtronic/Ardian, Renal denervation with EnligHTN St. Jude Medical and Renal denervation with Paradise Recor in people with Hypertension and Heart Failure, run by University Hospital, Saarland at 1 site in Germany.
Trial summary
The study is aiming to document the long-term safety and effectiveness of renal denervation in patients with hypertension and other diseases characterized by elevated sympathetic drive. Catheter-based renal denervation will be performed using CE marked, percutaneous, systems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Heart Failure, Chronic Kidney Disease
- What is being tested?
- Renal denervation with Symplicity Flex Medtronic/Ardian, Renal denervation with EnligHTN St. Jude Medical and Renal denervation with Paradise Recor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Jan 2021
- Phase
- Phase 1/2
- 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
Who may be able to join
- Individual is 18 years of age.
- Individual agrees to have all procedures performed, and is competent and willing to provide written, informed consent to participate in the registry.
- Patient scheduled for renal sympathetic denervation using market-released device.
Who cannot join
- In the eyes of the treating physician, the renal artery anatomy would interfere with safe cannulation of the renal artery or meets local standards for surgical repair.
- Individual has any serious medical condition, which in the opinion of the treating physician may adversely affect the safety and/or effectiveness of the participant (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, significant anemia, etc.).
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Saarland
Homburg/Saar, 66421
Michael Böhm, MD
Felix Mahfoud, MD
About this study
Official title: Safety and Efficacy Study Investigating the Effects of Catheter-based Renal Denervation on Different Organ Systems in Patients With Increased Sympathetic Activity
The study is aiming to document the long-term safety and effectiveness of renal denervation in patients with hypertension and other diseases characterized by elevated sympathetic drive. Catheter-based renal denervation will be performed using CE marked, percutaneous, systems.
Read the detailed description
Inclusion Criteria
- Individual is 18 years of age.
- Individual agrees to have all procedures performed, and is competent and willing to provide written, informed consent to participate in the registry.
- Patient scheduled for renal sympathetic denervation using market-released device.
Exclusion Criteria
- In the eyes of the treating physician, the renal artery anatomy would interfere with safe cannulation of the renal artery or meets local standards for surgical repair.
- Individual has any serious medical condition, which in the opinion of the treating physician may adversely affect the safety and/or effectiveness of the participant (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, significant anemia, etc.).
- Being tested
- Renal denervation with Symplicity Flex Medtronic/Ardian, Renal denervation with EnligHTN St. Jude Medical, Renal denervation with Paradise Recor, Renal denervation with V2 Vessix
- Keywords
- Hypertension, Heart Failure, Sympathetic activity
- Medical subject headings
- Hypertension, Heart Failure, Renal Insufficiency, Chronic, Diabetes Mellitus, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal denervation with Symplicity Flex Medtronic/ArdianDevice
Renal denervation using CE-marked devices will be performed according to best medical practice.
Renal denervation with EnligHTN St. Jude MedicalDevice
Renal denervation using CE-marked devices will be performed according to best medical practice.
Renal denervation with Paradise RecorDevice
Renal denervation using CE-marked devices will be performed according to best medical practice.
Renal denervation with V2 VessixDevice
Renal denervation using CE-marked devices will be performed according to best medical practice.
| Study group | Role | What they receive |
|---|---|---|
| Catheter-based renal denervation | Experimental | One procedure will be performed using one of the CE-marked devices for renal denervation:
Device: Renal denervation with Symplicity Flex Medtronic/Ardian Device: Renal denervation with EnligHTN St. Jude Medical Device: Renal denervation with Paradise Recor Device: Renal denervation with V2 Vessix Receives: Device: Renal denervation with Symplicity Flex Medtronic/Ardian; Device: Renal denervation with EnligHTN St. Jude Medical; Device: Renal denervation with Paradise Recor; Device: Renal denervation with V2 Vessix |
| Medical therapy | No intervention | Best medical therapy using guideline recommended drugs in each disease state. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and efficacy of renal denervation
Effect on blood pressure including office, ABPM, and home-based measurements.
Number of adverse events (death, stroke, myocardial infarction, new dialysis, and congestive heart failure).
Changes of antihypertensive medications.
Effects on renal function assessed with glomerular filtration rate.
Renovascular safety (renal artery stenosis) assessed by duplex ultrasound.
Measured: Baseline to 6 months
Secondary outcomes (2)
Effect of renal denervation on different organ systems.
Myocardial function and geometry using echo and MRI.
Heart rate changes and arrhythmias.
Glucose metabolism and insulin resistance (fasting and during oGTT).
Hospitalization rates (eg. hypertensive emergencies, heart failure, etc).
Measured: Baseline, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Safety and efficacy of renal denervation
Effect on blood pressure including office, ABPM, and home-based measurements.
Number of adverse events (death, stroke, myocardial infarction, new dialysis, and congestive heart failure).
Changes of antihypertensive medications.
Effects on renal function assessed with glomerular filtration rate.
Renovascular safety (renal artery stenosis) assessed by duplex ultrasound.
Measured: Baseline, 3, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startJan 2011
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (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 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Saarland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Felix Mahfoud, MD, Study director, University Hospital, SaarlandMichael Böhm, MD, Principal investigator, University Hospital, Saarland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888315
- Sponsor's protocol ID
- Symplicity Extension
- Status last verified
- Jun 2013
- First submitted
- 4 Sep 2012
- Last updated
- 27 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Lauder L, Siwy J, Mavrogeorgis E, Keller F, Kunz M, Wachter A, Emrich IE, Bohm M, Mischak H, Mahfoud F. Impact of Renal Denervation on Urinary Peptide-Based Biomarkers in Hypertension. Hypertension. 2024 Jun;81(6):1374-1382. doi: 10.1161/HYPERTENSIONAHA.124.22819. Epub 2024 Apr 4.
PubMed 38572643
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study Investigating the Effects of Catheter-based Renal Denervation on Different Organ Systems in Patients With Increased Sympathetic Activity
- ClinicalTrials.gov ID
- NCT01888315
- Acronym / sponsor ID
- Symplicity Extension
- Keywords
- Hypertension, Heart Failure, Sympathetic activity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, SaarlandUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 27 Jun 2013 (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 study is aiming to document the long-term safety and effectiveness of renal denervation in patients with hypertension and other diseases characterized by elevated sympathetic drive. Catheter-based renal denervation will be performed using CE marked, percutaneous, systems.
Detailed description
Inclusion Criteria
- Individual is 18 years of age.
- Individual agrees to have all procedures performed, and is competent and willing to provide written, informed consent to participate in the registry.
- Patient scheduled for renal sympathetic denervation using market-released device.
Exclusion Criteria
- In the eyes of the treating physician, the renal artery anatomy would interfere with safe cannulation of the renal artery or meets local standards for surgical repair.
- Individual has any serious medical condition, which in the opinion of the treating physician may adversely affect the safety and/or effectiveness of the participant (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, significant anemia, etc.).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheter-based renal denervation | Experimental | Device: Renal denervation with Symplicity Flex Medtronic/Ardian, Device: Renal denervation with EnligHTN St. Jude Medical, Device: Renal denervation with Paradise Recor, Device: Renal denervation with V2 VessixOne procedure will be performed using one of the CE-marked devices for renal denervation: Device: Renal denervation with Symplicity Flex Medtronic/Ardian Device: Renal denervation with EnligHTN St. Jude Medical Device: Renal denervation with Paradise Recor Device: Renal denervation with V2 Vessix |
| Medical therapy | No intervention | –Best medical therapy using guideline recommended drugs in each disease state. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individual is 18 years of age.
- Individual agrees to have all procedures performed, and is competent and willing to provide written, informed consent to participate in the registry.
- Patient scheduled for renal sympathetic denervation using market-released device.
Key exclusion criteria (2 listed)
- In the eyes of the treating physician, the renal artery anatomy would interfere with safe cannulation of the renal artery or meets local standards for surgical repair.
- Individual has any serious medical condition, which in the opinion of the treating physician may adversely affect the safety and/or effectiveness of the participant (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, significant anemia, etc.).
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 with Symplicity Flex Medtronic/ArdianRenal denervation using CE-marked devices will be performed according to best medical practice. | Device | Catheter-based renal denervation |
| Renal denervation with EnligHTN St. Jude MedicalRenal denervation using CE-marked devices will be performed according to best medical practice. | Device | Catheter-based renal denervation |
| Renal denervation with Paradise RecorRenal denervation using CE-marked devices will be performed according to best medical practice. | Device | Catheter-based renal denervation |
| Renal denervation with V2 VessixRenal denervation using CE-marked devices will be performed according to best medical practice. | Device | Catheter-based renal denervation |
Primary outcome
Safety and efficacy of renal denervation
Time frame: Baseline to 6 months
Effect on blood pressure including office, ABPM, and home-based measurements. Number of adverse events (death, stroke, myocardial infarction, new dialysis, and congestive heart failure). Changes of antihypertensive medications. Effects on renal function assessed with glomerular filtration rate. Renovascular safety (renal artery stenosis) assessed by duplex ultrasound.
2 secondary outcomes
Effect of renal denervation on different organ systems.
Time frame: Baseline, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Safety and efficacy of renal denervation
Time frame: Baseline, 3, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2013.
- Derived from this study: PubMed 38572643Lauder L, Siwy J, Mavrogeorgis E, Keller F, Kunz M, Wachter A, Emrich IE, Bohm M, Mischak H, Mahfoud F. Impact of Renal Denervation on Urinary Peptide-Based Biomarkers in Hypertension. Hypertension. 2024 Jun;81(6):1374-1382. doi: 10.1161/HYPERTENSIONAHA.124.22819. Epub 2024 Apr 4.
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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.
Felix Mahfoud, MD study director
University Hospital, Saarland
Michael Böhm, MD principal investigator
University Hospital, Saarland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Renal denervation with Symplicity Flex Medtronic/Ardian, Renal denervation with EnligHTN St. Jude Medical and Renal denervation with Paradise Recor in people with Hypertension and Heart Failure, run by University Hospital, Saarland 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 3 inclusion and 2 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 27 Jun 2013. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Felix Mahfoud, MD (+4968411621346, felix.mahfoud@uks.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and efficacy of renal denervation (time frame: Baseline to 6 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 NCT01888315, 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 27 Jun 2013.