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

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ClinicalTrials.gov Identifier: NCT01888315
Recruitment Status : Recruiting
First Posted : June 27, 2013
Last Update Posted : June 27, 2013
Sponsor:
Information provided by (Responsible Party):
University Hospital, Saarland

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment 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

Detailed Description:

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.).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2011
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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).


  2. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.).
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University Hospital, Saarland
ClinicalTrials.gov Identifier: NCT01888315     History of Changes
Other Study ID Numbers: Symplicity Extension
First Posted: June 27, 2013    Key Record Dates
Last Update Posted: June 27, 2013
Last Verified: June 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