Prospective Evaluation of Confirmatory Testing For Primary Aldosteronism

Active, not recruiting

• Conditions: Primary Aldosteronism

• Registration Number: NCT04422756
• Lead Sponsor: University of Calgary

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 stimulation test for the diagnosis of primary aldosteronism, using disease-specific treatment response as a reference gold standard. Subjects consenting to study participation will undergo a standardized seated saline infusion test, followed by an ultra low-dose ACTH stimulation test. All participants also receive adrenal vein sampling. Individuals who have unilateral disease and desire surgery will receive adrenalectomy (as part of routine care) and the remaining subjects will receive medical treatment with a mineralocorticoid receptor antagonist. Response to targeted treatment will be considered the reference gold standard for the establishing the diagnosis of primary aldosteronism.

Study Timeline

• Study Start: 2017-01-15
• Study First Submitted: 2020-05-27
• Study First Submitted QC: 2020-06-05
• Study First Posted: 2020-06-09
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-25
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 183

Inclusion Criteria

• 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).

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of confirmatory testing (seated saline infusion test and the ultra low-dose ACTH stimulation test)	The total study timeline will occur over 66 months.	Measures of diagnostic accuracy, as summarized by receiver operating characteristic curve analyses.

Secondary Outcome Measures

Name	Time	Method
The optimal cutoff value for confirmatory testing using clinically-important thresholds	The total study timeline will occur over 66 months.	Aldosterone-to-renin ratio

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada