Status:
COMPLETED
Prospective Evaluation of Confirmatory Testing for Primary Aldosteronism
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Hypertension Canada
Conditions:
Primary Aldosteronism
Eligibility:
All Genders
18+ years
Brief Summary
This study is to evaluate the performance characteristics of the seated saline infusion test and the ultra low-dose ACTH stimulation test for the diagnosis of primary aldosteronism.
Detailed Description
This is a prospective study (with a target recruitment of 200 participants) designed to evaluate the performance characteristics of the seated saline infusion test and the ultra low-dose ACTH stimulat...
Eligibility Criteria
Inclusion
- Individuals with hypertension
- Individuals with an elevated screening adrenal renin ration (ARR)
- Individuals with high probability features of primary aldosteronism (e.g., resistant hypertension, spontaneous or diuretic-induced hypokalemia, and/or an adrenal nodule) with clinical indications for adrenal vein sampling and surgery (if appropriate).
Exclusion
- Individuals with chronic kidney disease (estimated glomerular filtration rate \<40 mL/min/1.73m2),
- Individuals with a history of heart failure, chronic edema, uncontrolled severe hypertension (systolic blood pressure \>180 and/or diastolic blood pressure \>110 mmHg), untreated hypokalemia, cortisol-secreting adrenal adenoma, and/or pheochromocytoma
- Individual who previously received confirmatory testing.
Key Trial Info
Start Date :
January 15 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 31 2024
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT04422756
Start Date
January 15 2017
End Date
August 31 2024
Last Update
March 30 2025
Active Locations (1)
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1
University of Calgary
Calgary, Alberta, Canada