Prospective Evaluation of Confirmatory Testing for Primary Aldosteronism

University of Calgary183 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

183

Conditions

Primary Aldosteronism

Interventions

Seated intravenous saline infusion testDIAGNOSTIC_TEST

The test will be conducted by infusing two litres of normal saline intravenously over 4 hours with the patient seated.Blood collection (for aldosterone, cortisol, renin, and electrolytes) will be performed at baseline and after completion of the infusion. Following infusion, plasma aldosterone levels \<140 pmol/L will be considered as "negative," levels \>280 pmol/L as "positive," and levels in between classified as indeterminate.

Ultra low-dose ACTH stimulation testDIAGNOSTIC_TEST

The test will be performed by injecting 0.03 mcg of ACTH intravenously. Blood collection (for aldosterone, cortisol, and renin) will be performed at baseline and after 15 minutes. We expect a "positive" response to correspond with a plasma aldosterone \>2200 pmol/L and ARR \>220 pmol/L/mIU/L following stimulation.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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). 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.

Locations (1)

University of Calgary

Calgary, Alberta, Canada

Outcomes

Primary Outcomes

Diagnostic accuracy of confirmatory testing (seated saline infusion test and the ultra low-dose ACTH stimulation test)

Measures of diagnostic accuracy, as summarized by receiver operating characteristic curve analyses.

Time frame: The total study timeline will occur over 66 months.

Secondary Outcomes

The optimal cutoff value for confirmatory testing using clinically-important thresholds

Plasma aldosterone

Time frame: The total study timeline will occur over 66 months.

The optimal cutoff value for confirmatory testing using clinically-important thresholds

Aldosterone-to-renin ratio

Time frame: The total study timeline will occur over 66 months.

Data from ClinicalTrials.gov

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