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Influence of Catheter-based Renal Denervation in Diseases With Increased Sympathetic Activity
This study is currently recruiting participants.
Verified June 2013 by University Hospital, Saarland
Sponsor:
University Hospital, Saarland
Information provided by (Responsible Party):
University Hospital, Saarland
ClinicalTrials.gov Identifier:
NCT01888315
First received: September 4, 2012
Last updated: June 24, 2013
Last verified: June 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Hypertension Heart Failure Chronic Kidney Disease Diabetes Heart Rhythm Disorders | 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 | Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Safety and Efficacy Study Investigating the Effects of Catheter-based Renal Denervation on Different Organ Systems in Patients With Increased Sympathetic Activity |
Further study details as provided by University Hospital, Saarland:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- Effect of renal denervation on different organ systems. [ Time Frame: Baseline, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months ]
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).
- Safety and efficacy of renal denervation [ Time Frame: Baseline, 3, 12, 18, 24, 30, 36, 42, 48, 54, 60 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.
| Estimated Enrollment: | 1000 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | January 2021 |
| Estimated Primary Completion Date: | January 2021 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Catheter-based renal denervation
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 |
Device: Renal denervation with Symplicity Flex Medtronic/Ardian
Renal denervation using CE-marked devices will be performed according to best medical practice.
Device: Renal denervation with EnligHTN St. Jude Medical
Renal denervation using CE-marked devices will be performed according to best medical practice.
Device: Renal denervation with Paradise Recor
Renal denervation using CE-marked devices will be performed according to best medical practice.
Device: Renal denervation with V2 Vessix
Renal denervation using CE-marked devices will be performed according to best medical practice.
|
|
No Intervention: Medical therapy
Best medical therapy using guideline recommended drugs in each disease state.
|
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.).
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.).
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01888315
Please refer to this study by its ClinicalTrials.gov identifier: NCT01888315
Contacts
| Contact: Felix Mahfoud, MD | +4968411621346 | felix.mahfoud@uks.eu | |
| Contact: Michael Böhm, MD | +4968411623372 | michael.boehm@uks.eu |
Locations
| Germany | |
| University Hospital Saarland | Recruiting |
| Homburg/Saar, Germany, 66421 | |
| Contact: Michael Böhm, MD | |
| Contact: Felix Mahfoud, MD | |
Sponsors and Collaborators
University Hospital, Saarland
Investigators
| Study Director: | Felix Mahfoud, MD | University Hospital, Saarland |
| Principal Investigator: | Michael Böhm, MD | University Hospital, Saarland |
More Information
| Responsible Party: | University Hospital, Saarland |
| ClinicalTrials.gov Identifier: | NCT01888315 History of Changes |
| Other Study ID Numbers: |
Symplicity Extension |
| Study First Received: | September 4, 2012 |
| Last Updated: | June 24, 2013 |
Keywords provided by University Hospital, Saarland:
|
Hypertension Heart Failure Sympathetic activity |
Additional relevant MeSH terms:
|
Hypertension Heart Failure Kidney Diseases Renal Insufficiency, Chronic Arrhythmias, Cardiac Vascular Diseases |
Cardiovascular Diseases Heart Diseases Urologic Diseases Renal Insufficiency Pathologic Processes |
ClinicalTrials.gov processed this record on June 26, 2017