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The effect of Renal Denervation on Renal Flow in Humans

Completed
Conditions
10057166
high blood pressure
intrarenal flow
Registration Number
NL-OMON39747
Lead Sponsor
niversitair Medisch Centrum Utrecht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
20
Inclusion Criteria

1. Individual is accepted for treatment with renal denervation as standard therapy for resistant hypertension.
2. Individual is >=18 years of age.
3.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

1.Individual is excluded from treatment with pRDN .
2.Individual has an estimated glomerular filtration rate (eGFR) of <30mL/min/1.73m2, using the MDRD calculation.
3.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.
4.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).
5.Individual is pregnant, nursing or planning to be pregnant.
6.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.

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Primarily the effect of pRDN on renal blood flow, assessed by a change in<br /><br>average peak flow velocity, both in baseline as well as hyperaemic conditions. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>The effect of pRDN on renal flow reserve (RFR), and hyperaemic microvascular<br /><br>resistance (HMR). </p><br>
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