The Effect of Renal Denervation on Renal Flow in Humans

This study is currently recruiting participants.
Verified May 2013 by UMC Utrecht
Information provided by (Responsible Party):
W.I. Verloop, UMC Utrecht Identifier:
First received: April 26, 2013
Last updated: May 6, 2013
Last verified: May 2013

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.

Condition Intervention
Procedure: Renal Denervation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: The Effect of Renal Denervation on Renal Flow in Humans

Resource links provided by NLM:

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Change in microvascular resistance [ Time Frame: Within 30 minutes after renal denervation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in average flow velocity [ Time Frame: within 30 minutes after renal denervation ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • safety of measurement [ Time Frame: within 24 hour after renal denervation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: April 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients undergoing renal denervation
patients diagnosed with resistant hypertension, eligible to undergo renal denervation
Procedure: Renal Denervation
Flowmeasurements will be performed before and after renal denervation
Other Name: flowmeasurements


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Please refer to this study by its identifier: NCT01848314

Contact: Willemien L. Verloop, MD 0031 88 7559447

UMC Utrecht Recruiting
Utrecht, Netherlands, 3584CX
Contact: Willemien Verloop, MD    0031887559447   
Contact: Michiel Voskuil   
Sub-Investigator: Willemien Verloop, MD         
Sponsors and Collaborators
UMC Utrecht
Principal Investigator: Michiel Voskuil, MD, PhD UMC Utrecht
  More Information

No publications provided

Responsible Party: W.I. Verloop, MD, UMC Utrecht Identifier: NCT01848314     History of Changes
Other Study ID Numbers: NL42766.041.12
Study First Received: April 26, 2013
Last Updated: May 6, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases processed this record on April 17, 2014