The Effect of Renal Denervation on Renal Flow in Humans
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2013 by UMC Utrecht.
Recruitment status was Recruiting
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.
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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
||Michiel Voskuil, MD, PhD
No publications provided
ClinicalTrials.gov processed this record on May 26, 2015
||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)