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Influence of Catheter-based Renal Denervation in Diseases With Increased Sympathetic Activity

Primary Purpose

Hypertension, Heart Failure, Chronic Kidney Disease

Status
Unknown status
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Renal denervation with Symplicity Flex Medtronic/Ardian
Renal denervation with EnligHTN St. Jude Medical
Renal denervation with Paradise Recor
Renal denervation with V2 Vessix
Sponsored by
University Hospital, Saarland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Heart Failure, Sympathetic activity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  1. Individual is 18 years of age.
  2. Individual agrees to have all procedures performed, and is competent and willing to provide written, informed consent to participate in the registry.
  3. Patient scheduled for renal sympathetic denervation using market-released device.

Exclusion Criteria

  1. 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.
  2. 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.).

Sites / Locations

  • University Hospital SaarlandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Catheter-based renal denervation

Medical therapy

Arm Description

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

Best medical therapy using guideline recommended drugs in each disease state.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.

Full Information

First Posted
September 4, 2012
Last Updated
June 24, 2013
Sponsor
University Hospital, Saarland
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1. Study Identification

Unique Protocol Identification Number
NCT01888315
Brief Title
Influence of Catheter-based Renal Denervation in Diseases With Increased Sympathetic Activity
Official Title
Safety and Efficacy Study Investigating the Effects of Catheter-based Renal Denervation on Different Organ Systems in Patients With Increased Sympathetic Activity
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Saarland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Heart Failure, Chronic Kidney Disease, Diabetes, Heart Rhythm Disorders
Keywords
Hypertension, Heart Failure, Sympathetic activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Catheter-based renal denervation
Arm Type
Experimental
Arm Description
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
Arm Title
Medical therapy
Arm Type
No Intervention
Arm Description
Best medical therapy using guideline recommended drugs in each disease state.
Intervention Type
Device
Intervention Name(s)
Renal denervation with Symplicity Flex Medtronic/Ardian
Intervention Description
Renal denervation using CE-marked devices will be performed according to best medical practice.
Intervention Type
Device
Intervention Name(s)
Renal denervation with EnligHTN St. Jude Medical
Intervention Description
Renal denervation using CE-marked devices will be performed according to best medical practice.
Intervention Type
Device
Intervention Name(s)
Renal denervation with Paradise Recor
Intervention Description
Renal denervation using CE-marked devices will be performed according to best medical practice.
Intervention Type
Device
Intervention Name(s)
Renal denervation with V2 Vessix
Intervention Description
Renal denervation using CE-marked devices will be performed according to best medical practice.
Primary Outcome Measure Information:
Title
Safety and efficacy of renal denervation
Description
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.
Time Frame
Baseline to 6 months
Secondary Outcome Measure Information:
Title
Effect of renal denervation on different organ systems.
Description
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).
Time Frame
Baseline, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Title
Safety and efficacy of renal denervation
Description
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.
Time Frame
Baseline, 3, 12, 18, 24, 30, 36, 42, 48, 54, 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Felix Mahfoud, MD
Phone
+4968411621346
Email
felix.mahfoud@uks.eu
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Böhm, MD
Phone
+4968411623372
Email
michael.boehm@uks.eu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felix Mahfoud, MD
Organizational Affiliation
University Hospital, Saarland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Michael Böhm, MD
Organizational Affiliation
University Hospital, Saarland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Saarland
City
Homburg/Saar
ZIP/Postal Code
66421
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Böhm, MD
First Name & Middle Initial & Last Name & Degree
Felix Mahfoud, MD

12. IPD Sharing Statement

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Influence of Catheter-based Renal Denervation in Diseases With Increased Sympathetic Activity

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