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
  Purpose

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
Hypertension
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

  Eligibility

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

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
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: NCT01848314

Contacts
Contact: Willemien L. Verloop, MD 0031 88 7559447 w.l.verloop@umcutrecht.nl

Locations
Netherlands
UMC Utrecht Recruiting
Utrecht, Netherlands, 3584CX
Contact: Willemien Verloop, MD    0031887559447    w.l.verloop@umcutrecht.nl   
Contact: Michiel Voskuil       m.voskuil@umcutrecht.nl   
Sub-Investigator: Willemien Verloop, MD         
Sponsors and Collaborators
UMC Utrecht
Investigators
Principal Investigator: Michiel Voskuil, MD, PhD UMC Utrecht
  More Information

No publications provided

Responsible Party: W.I. Verloop, MD, UMC Utrecht
ClinicalTrials.gov 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:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014