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The Effect of Renal Denervation on Renal Flow in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01848314
Recruitment Status : Completed
First Posted : May 7, 2013
Last Update Posted : June 8, 2015
Sponsor:
Information provided by (Responsible Party):
W.I. Verloop, UMC Utrecht

Tracking Information
First Submitted Date  ICMJE April 26, 2013
First Posted Date  ICMJE May 7, 2013
Last Update Posted Date June 8, 2015
Study Start Date  ICMJE April 2013
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2013)
Change in microvascular resistance [ Time Frame: Within 30 minutes after renal denervation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01848314 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2013)
change in average flow velocity [ Time Frame: within 30 minutes after renal denervation ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 6, 2013)
safety of measurement [ Time Frame: within 24 hour after renal denervation ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effect of Renal Denervation on Renal Flow in Humans
Official Title  ICMJE The Effect of Renal Denervation on Renal Flow in Humans
Brief Summary Many studies have studied the effect and safety of renal denervation. However, it remains unknown what the exact mechanism behind renal denervation is. It can be hypothesized that a difference in renal blood flow occurs after treatment. In the light of this ignorance, current study will investigate whether renal denervation leads to a difference in renal blood flow after treatment with renal denervation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Hypertension
Intervention  ICMJE Procedure: Renal Denervation
Flowmeasurements will be performed before and after renal denervation
Other Name: flowmeasurements
Study Arms  ICMJE Experimental: Patients undergoing renal denervation
patients diagnosed with resistant hypertension, eligible to undergo renal denervation
Intervention: Procedure: Renal Denervation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 4, 2015)
15
Original Estimated Enrollment  ICMJE
 (submitted: May 6, 2013)
20
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Individual is scheduled to undergo renal denervation as standard patient care for resistant hypertension.
  • Individual is diagnosed with resistant hypertension. Secondary causes and a white coat hypertension are actively excluded.
  • Individual is ≥18 years of age.
  • Individual agrees to have all study procedures performed, and is competent and willing to provide written informed consent to participate in this clinical study.

Exclusion Criteria:

  • Individual is excluded from treatment with pRDN .
  • Individual has an estimated glomerular filtration rate (eGFR) of <30mL/min/1.73m2, using the MDRD calculation.
  • Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months of the screening visit, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
  • Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, haemophilia or significant anaemia).
  • Individual is pregnant, nursing or planning to be pregnant.
  • Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01848314
Other Study ID Numbers  ICMJE NL42766.041.12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party W.I. Verloop, UMC Utrecht
Study Sponsor  ICMJE UMC Utrecht
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michiel Voskuil, MD, PhD UMC Utrecht
PRS Account UMC Utrecht
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP