Nationwide, Pragmatic, Direct-to-Patient Primary Aldosteronism Testing Program

BACKGROUND: Primary aldosteronism, an endocrinopathy present in ≥10% to 25% of patients with hypertension, confers excess cardiovascular risk that can be mitigated with aldosterone-directed therapy. However, only 2% of eligible patients undergo guideline-recommended screening. This study aimed to bypass clinical inertia and identify people with primary aldosteronism using pragmatic, direct-to-patient testing. METHODS: Hypertensive adults were recruited via online platforms and underwent virtual consent and local phlebotomy. Using a standardized diagnostic algorithm, laboratory results with interpretations were communicated to patients and primary care providers. Follow-up was ascertained at 6 to 12 months. The primary outcome was the frequency of a positive test for primary aldosteronism. Secondary outcomes included follow-up primary aldosteronism testing and implementation of aldosterone-targeted therapies. RESULTS: The study population (N=694) had a mean age of 63.3±11.3 years, was 52.2% female, and hailed from 41 US states. Overall, 25.4% had a positive test for primary aldosteronism. Sleep apnea, resistant hypertension, and hypokalemia were the most common testing indications, with 55.2% of participants having ≥2 indications. Over half of participants (57%) were already under endocrinology, cardiology, or nephrology care, yet had not been tested. In longitudinal follow-up of participants with a positive result, 25.5% had additional testing and 13.7% were started on aldosterone-targeted therapy (mineralocorticoid receptor antagonist or adrenalectomy). CONCLUSIONS: Pragmatic, direct-to-patient testing, and simplified results interpretation is a feasible, scalable method to increase primary aldosteronism diagnoses and implementation of aldosterone-targeted therapies. Given that new hypertension guidelines recommend primary aldosteronism screening in all hypertensive people, practical approaches to test, interpret, and implement results will be essential.