HypertensionISAR-denerveNCT01899456
Impact of Sympathetic Renal Denervation- a Study in Patients After Renal Transplantation
A study testing Catheter-based renal denervation in people with Hypertension and Chronic Kidney Disease, run by Technical University of Munich at 1 site in Germany.
Trial summary
The study is aiming to document the safety and effectiveness of renal denervation in patients after renal transplantation with hypertension. Catheter-based renal denervation will be performed using CE marked, percutaneous Symplicity catheter. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertension, Chronic Kidney Disease, Renal Transplantation
- What is being tested?
- Catheter-based renal denervation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2013to Nov 2015
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient after renal transplantation (> 6 month) without resection of native kidneys
- systolic blood pressure >=150 mmHg
- on 3 or more antihypertensive medications
- 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.
Who cannot join
- secondary causes and a white coat hypertension
- renal artery abnormalities
- eGFR < 30mL/min (MDRD)
- angina
- severe Aortic valve stenosis
- Individual is pregnant, nursing or planning to be pregnant
- other
Trial locations and contacts
1 site in 1 country.
Germany1 site
1. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, Technische Universität München
Munich, 81675
About this study
Official title: A Randomized Safety and Efficacy Study Investigating the Effects of Catheter-based Renal Denervation in Patients After Renal Transplantation
The study is aiming to document the safety and effectiveness of renal denervation in patients after renal transplantation with hypertension. Catheter-based renal denervation will be performed using CE marked, percutaneous Symplicity catheter.
- Being tested
- Catheter-based renal denervation
- Medical subject headings
- Hypertension, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter-based renal denervationDevice
Also called Renal denervation with Symplicity Catheter Medtronic/Ardian
| Study group | Role | What they receive |
|---|---|---|
| Medical therapy | No intervention | Best medical therapy using guideline recommended drugs in each disease state. |
| Catheter-based renal denervation | Experimental | Renal denervation will be performed in the native renal arteries of patients after renal transplantation. Access side is the contralateral femoral artery. Receives: Device: Catheter-based renal denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and efficacy of renal denervation in patients after renal transplantation
Effect on blood pressure including office, ABPM, and home-based measurements. Number of adverse events. 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 (1)
Effect of renal denervation in patients after renal transplantation on different organ systems.
Effects on sympathetic activity assessed by heart rate variability and post extrasystolic potentiation. Glucose metabolism and insulin resistance (fasting and during oGTT). Hospitalization rates (eg. hypertensive emergencies, heart failure, etc).
Measured: Baseline to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionMar 2015
- Study completionNov 2015
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.
- More trials run by Technical University of MunichThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Schneider, Technical University of Munich
- Investigators
- Simon Schneider, MD, Principal investigator, 1. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, Technische Unversität München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899456
- Sponsor's protocol ID
- 5548/12
- Acronym
- ISAR-denerve
- Status last verified
- Nov 2015
- First submitted
- 10 Jul 2013
- Last updated
- 5 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Schneider S, Promny D, Sinnecker D, Byrne RA, Muller A, Dommasch M, Wildenauer A, Schmidt G, Heemann U, Laugwitz KL, Baumann M. Impact of sympathetic renal denervation: a randomized study in patients after renal transplantation (ISAR-denerve). Nephrol Dial Transplant. 2015 Nov;30(11):1928-36. doi: 10.1093/ndt/gfv311. Epub 2015 Sep 1.
PubMed 26333545
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Safety and Efficacy Study Investigating the Effects of Catheter-based Renal Denervation in Patients After Renal Transplantation
- ClinicalTrials.gov ID
- NCT01899456
- Acronym / sponsor ID
- ISAR-denerve / 5548/12
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 15 Jul 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 safety and effectiveness of renal denervation in patients after renal transplantation with hypertension. Catheter-based renal denervation will be performed using CE marked, percutaneous Symplicity catheter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical therapy | No intervention | –Best medical therapy using guideline recommended drugs in each disease state. |
| Catheter-based renal denervation | Experimental | Device: Catheter-based renal denervationRenal denervation will be performed in the native renal arteries of patients after renal transplantation. Access side is the contralateral femoral artery. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient after renal transplantation (> 6 month) without resection of native kidneys
- systolic blood pressure >=150 mmHg
- on 3 or more antihypertensive medications
- 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.
Key exclusion criteria (7 listed)
- secondary causes and a white coat hypertension
- renal artery abnormalities
- eGFR < 30mL/min (MDRD)
- angina
- severe Aortic valve stenosis
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 |
|---|---|---|
| Catheter-based renal denervationAlso: Renal denervation with Symplicity Catheter Medtronic/Ardian | Device | Catheter-based renal denervation |
Primary outcome
Safety and efficacy of renal denervation in patients after renal transplantation
Time frame: Baseline to 6 months
Effect on blood pressure including office, ABPM, and home-based measurements. Number of adverse events. Changes of antihypertensive medications. Effects on renal function assessed with glomerular filtration rate. Renovascular safety (renal artery stenosis) assessed by duplex ultrasound.
1 secondary outcome
Effect of renal denervation in patients after renal transplantation on different organ systems.
Time frame: Baseline to 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2015.
- Results publication: PubMed 26333545Schneider S, Promny D, Sinnecker D, Byrne RA, Muller A, Dommasch M, Wildenauer A, Schmidt G, Heemann U, Laugwitz KL, Baumann M. Impact of sympathetic renal denervation: a randomized study in patients after renal transplantation (ISAR-denerve). Nephrol Dial Transplant. 2015 Nov;30(11):1928-36. doi: 10.1093/ndt/gfv311. Epub 2015 Sep 1.
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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.
Simon Schneider, MD principal investigator
1. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, Technische Unversität München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter-based renal denervation in people with Hypertension and Chronic Kidney Disease, run by Technical University of Munich 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 5 inclusion and 7 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 5 Nov 2015. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and efficacy of renal denervation in patients after renal transplantation (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 NCT01899456, 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 5 Nov 2015.