Native Kidney Denervation in Patients With End Stage Renal Disease
November 2, 2012 updated by: Medtronic Vascular
To investigate the utility of renal denervation in the treatment of patients with End Stage Renal Disease (ESRD).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adult >= 18 years of age
- end stage renal disease, undergoing concurrent dialysis treatment
- poorly controlled blood pressure on at least 2 antihypertensive drugs
- agrees to have the study procedure(s) performed and additional procedures and evaluations, including interventions and follow up visits
- competent and willing to provide written, informed consent to participate in this clinical study.
Exclusion Criteria:
- renal arterial abnormalities
- myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within six (6) months
- hemodynamically significant valvular heart disease
- implantable cardioverter defibrillator (ICD) or pacemaker
- respiratory support.
- pregnant, nursing or planning to be pregnant
- other
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To provide confirmation that renal denervation in ESRD patients is safe and feasible.
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Secondary Outcome Measures
Outcome Measure |
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To provide evidence of denervation, indication of physiologic response, and assess device performance.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Markus Schlaich, MD, The Alfred
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Schlaich MP, Hering D, Sobotka PA, Krum H, Esler MD. Renal denervation in human hypertension: mechanisms, current findings, and future prospects. Curr Hypertens Rep. 2012 Jun;14(3):247-53. doi: 10.1007/s11906-012-0264-9.
- Hering D, Esler MD, Krum H, Mahfoud F, Bohm M, Sobotka PA, Schlaich MP. Recent advances in the treatment of hypertension. Expert Rev Cardiovasc Ther. 2011 Jun;9(6):729-44. doi: 10.1586/erc.11.71.
- Schlaich MP, Sobotka PA, Krum H, Whitbourn R, Walton A, Esler MD. Renal denervation as a therapeutic approach for hypertension: novel implications for an old concept. Hypertension. 2009 Dec;54(6):1195-201. doi: 10.1161/HYPERTENSIONAHA.109.138610. Epub 2009 Oct 12. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Study Registration Dates
First Submitted
October 26, 2007
First Submitted That Met QC Criteria
October 26, 2007
First Posted (Estimate)
October 30, 2007
Study Record Updates
Last Update Posted (Estimate)
November 6, 2012
Last Update Submitted That Met QC Criteria
November 2, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TP-020 & TP-039
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.