The Effect of Renal Denervation on Renal Flow in Humans

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by UMC Utrecht
Sponsor:
Information provided by (Responsible Party):
W.I. Verloop, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01848314
First received: April 26, 2013
Last updated: May 6, 2013
Last verified: May 2013

April 26, 2013
May 6, 2013
April 2013
September 2013   (final data collection date for primary outcome measure)
Change in microvascular resistance [ Time Frame: Within 30 minutes after renal denervation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01848314 on ClinicalTrials.gov Archive Site
change in average flow velocity [ Time Frame: within 30 minutes after renal denervation ] [ Designated as safety issue: No ]
Same as current
safety of measurement [ Time Frame: within 24 hour after renal denervation ] [ Designated as safety issue: Yes ]
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
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Hypertension
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
May 2014
September 2013   (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.
Both
18 Years and older
No
Contact: Willemien L. Verloop, MD 0031 88 7559447 w.l.verloop@umcutrecht.nl
Netherlands
 
NCT01848314
NL42766.041.12
No
W.I. Verloop, UMC Utrecht
UMC Utrecht
Not Provided
Principal Investigator: Michiel Voskuil, MD, PhD UMC Utrecht
UMC Utrecht
May 2013

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