The effect of Renal Denervation on Renal Flow in Humans
- Conditions
- 10057166high blood pressureintrarenal 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
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.
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
Name Time Method <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
Name Time Method <p>The effect of pRDN on renal flow reserve (RFR), and hyperaemic microvascular<br /><br>resistance (HMR). </p><br>