Influence of Catheter-based Renal Denervation in Diseases With Increased Sympathetic Activity
Safety and Efficacy Study Investigating the Effects of Catheter-based Renal Denervation on Different Organ Systems in Patients With Increased Sympathetic Activity
1 other identifier
interventional
1,000
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 hypertension
Started Jan 2011
Longer than P75 for phase_1 hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 4, 2012
CompletedFirst Posted
Study publicly available on registry
June 27, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedJune 27, 2013
June 1, 2013
10 years
September 4, 2012
June 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline to 6 months
Secondary Outcomes (2)
Effect of renal denervation on different organ systems.
Baseline, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Safety and efficacy of renal denervation
Baseline, 3, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Study Arms (2)
Catheter-based renal denervation
EXPERIMENTALOne 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 INTERVENTIONBest medical therapy using guideline recommended drugs in each disease state.
Interventions
Renal denervation using CE-marked devices will be performed according to best medical practice.
Renal denervation using CE-marked devices will be performed according to best medical practice.
Renal denervation using CE-marked devices will be performed according to best medical practice.
Renal denervation using CE-marked devices will be performed according to best medical practice.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Saarland
Homburg/Saar, 66421, Germany
Related Publications (1)
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.
PMID: 38572643DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Felix Mahfoud, MD
University Hospital, Saarland
- PRINCIPAL INVESTIGATOR
Michael Böhm, MD
University Hospital, Saarland
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2012
First Posted
June 27, 2013
Study Start
January 1, 2011
Primary Completion
January 1, 2021
Study Completion
January 1, 2021
Last Updated
June 27, 2013
Record last verified: 2013-06