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Renal Functional Imaging for Non-invasive Evaluation and Diagnostics

Conditions
hypertensie
chronic kidney disease
loss of kidney function
10029149
Registration Number
NL-OMON45267
Lead Sponsor
niversitair Medisch Centrum Utrecht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
35
Inclusion Criteria

- Subject is >= 18 years of age
- Subject agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study;Exclusively for subjects in the CKD group:
- Subject has a GFR of 30-60 ml/min/1.73 m2 ;Exclusively for subjects in the hypertension group:
- Subject has a systolic blood pressure of >=140 mmHg and/or a diastolic blood pressure of >=90 mmHg based on average of 3 office blood pressure readings, or a 24-h ambulatory blood pressure of >=140 mmHg systolic and/or >=90 mmHg diastolic; or is on antihypertensive medication
- Subject has no treatable secondary cause of hypertension
- Subject has no medical record of impaired kidney function (as defined by a GFR <60 ml/min/1.73m2);Exclusively for healthy volunteers:
- Subject has no medical record of impaired kidney function (as defined by a GFR <60 ml/min/1.73m2)
- Subject has no medical record of hypertension (as defined by a systolic blood pressure of >=140 mmHg and/or a diastolic blood pressure of >=90; or the use of antihypertensive medication)
- Subject can be age matched within a range of ±5 years to one or more subjects in the CKD and hypertension groups

Exclusion Criteria

- Subject has an allergy or intolerance to any of the agents used in the study
- Subject has any contraindications for MRI according to screening protocol radiology department UMCU
- Subject is pregnant, nursing or planning to be pregnant
- Subject 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
- Subject refuses to be informed of chance findings possibly relevant to their health
- Subject is currently being treated with drugs that cause salt retention (e.g., systemic corticosteroids and fludrocortisone);Exclusively for healthy volunteers and hypertensive subjects:
- Subject has no known renal disease

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Agreement between GFR as measured with MRI and GFR as measured with inulin<br /><br>clearance. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>NA</p><br>
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