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. Identifier: NCT01848314
Recruitment Status : Completed
First Posted : May 7, 2013
Last Update Posted : June 8, 2015
Information provided by (Responsible Party):
W.I. Verloop, UMC Utrecht

April 26, 2013
May 7, 2013
June 8, 2015
April 2013
September 2014   (Final data collection date for primary outcome measure)
Change in microvascular resistance [ Time Frame: Within 30 minutes after renal denervation ]
Same as current
Complete list of historical versions of study NCT01848314 on Archive Site
change in average flow velocity [ Time Frame: within 30 minutes after renal denervation ]
Same as current
safety of measurement [ Time Frame: within 24 hour after renal denervation ]
Same as current
The Effect of Renal Denervation on Renal Flow in Humans
The Effect of Renal Denervation on Renal Flow in Humans
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.
Not Provided
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Procedure: Renal Denervation
Flowmeasurements will be performed before and after renal denervation
Other Name: flowmeasurements
Experimental: Patients undergoing renal denervation
patients diagnosed with resistant hypertension, eligible to undergo renal denervation
Intervention: Procedure: Renal Denervation
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2014
September 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
W.I. Verloop, UMC Utrecht
UMC Utrecht
Not Provided
Principal Investigator: Michiel Voskuil, MD, PhD UMC Utrecht
UMC Utrecht
June 2015

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