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Nationwide, Pragmatic, Direct-to-Patient Primary Aldosteronism Testing Program
Jenifer M Brown1,2,3, Laura C Tsai1,3, Eva E Abel1,2,3
1Division of Endocrinology, Diabetes, and Hypertension, Center for Adrenal Disorders (J.M.B., L.C.T., E.E.A., A.F., A.E.M., Y.M.N., B.B., B.H., J.M., K.F., A.J.N., W.W.P., A.V.), Harvard Medical School, Boston, MA.
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, 13.7% were started on aldosterone-targeted therapy (mineralocorticoid receptor antagonist or adrenalectomy), and 24.5% reported improved blood pressure control.
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.
Insights
Direct-to-patient testing effectively identifies primary aldosteronism, a condition linked to hypertension and cardiovascular risk. This pragmatic approach increases diagnoses and treatment initiation, improving patient outcomes.
Area of Science:
- Endocrinology
- Cardiovascular Medicine
- Hypertension Management
Background:
- Primary aldosteronism affects 10-25% of hypertensive patients, increasing cardiovascular risk.
- Aldosterone-directed therapy mitigates this risk, yet screening rates remain low (2%).
- Clinical inertia hinders timely diagnosis and treatment of primary aldosteronism.
Purpose of the Study:
- To bypass clinical inertia in primary aldosteronism diagnosis.
- To identify individuals with primary aldosteronism using direct-to-patient testing.
- To evaluate the feasibility and scalability of pragmatic diagnostic approaches.
Main Methods:
- Recruited hypertensive adults via online platforms with virtual consent.
- Utilized local phlebotomy for sample collection.
- Employed a standardized diagnostic algorithm with results communicated to patients and providers.
Main Results:
- 25.4% of 694 participants tested positive for primary aldosteronism.
- Common indications included sleep apnea, resistant hypertension, and hypokalemia.
- Despite specialist care, 57% of participants had not been previously tested.
Conclusions:
- Pragmatic, direct-to-patient testing increases primary aldosteronism diagnoses.
- Simplified interpretation and results delivery enhance treatment implementation.
- Scalable approaches are crucial for meeting new screening guidelines for all hypertensive individuals.
