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
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.
Procedure: Renal Denervation
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
||The Effect of Renal Denervation on Renal Flow in Humans
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||September 2013 (Final data collection date for primary outcome measure)
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:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01848314
||Michiel Voskuil, MD, PhD
No publications provided
||W.I. Verloop, MD, UMC Utrecht
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 26, 2013
||May 6, 2013
||Netherlands: Medical Ethics Review Committee (METC)
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014