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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University Hospital, Saarland
Sponsor:
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
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Saarland:

Primary Outcome Measures:
  • Safety and efficacy of renal denervation [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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

  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.).
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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

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

No publications provided

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
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital, Saarland:
Hypertension
Heart Failure
Sympathetic activity

Additional relevant MeSH terms:
Heart Failure
Hypertension
Renal Insufficiency, Chronic
Cardiovascular Diseases
Heart Diseases
 Kidney Diseases
Renal Insufficiency
Urologic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on March 02, 2015