Status:
COMPLETED
The Effect of Renal Denervation on Renal Flow in Humans
Lead Sponsor:
UMC Utrecht
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 rena...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01848314
Start Date
April 1 2013
End Date
September 1 2014
Last Update
June 8 2015
Active Locations (1)
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1
UMC Utrecht
Utrecht, Utrecht, Netherlands, 3584CX