Current Screening Thresholds May Miss Half of Patients with Primary Aldosterone, a Leading Cause of Severe High Blood Pressure, Finds Study in Hypertension
Broader laboratory criteria identified 26.2% of the study cohort as positive, versus 13.0% under the 2025 criteria.
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Quest Diagnostics (DGX) researchers coauthored a study suggesting broader screening criteria could double detection of primary aldosteronism, a hormonal cause of hypertension.
Published in Hypertension, the retrospective study used Quest laboratory results from over 60,449 U.S. patients. Broader criteria identified 26.2% as positive, versus 13.0% under the 2025 Endocrine Society criteria. The broader criteria lowered the aldosterone threshold and removed the aldosterone-to-renin ratio requirement. Additional patients identified also showed clinical conditions consistent with the disorder, based on insurance billing records. The findings suggest potential for earlier detection, but limitations include lack of confirmatory testing and the retrospective design.
Positive
- Minor pointBroader screening criteria identified 26.2% as positive for primary aldosteronism, versus 13.0% under 2025 criteria.
- Minor pointBroader-criteria positive patients showed enrichment of hypertension, low blood potassium and atrial fibrillation in insurance billing records.
- Minor pointAmong broader-criteria positives, plasma renin activity below 0.5 ng/mL/hr showed 1.27 times higher odds of hypertension versus higher or normal activity.
- Minor pointAmong broader-criteria positives, plasma renin activity below 0.25 ng/mL/hr showed 2.62 times higher odds of atrial fibrillation.
Negative
- Minor pointStudy limitations include a retrospective design and lack of confirmatory testing, limiting interpretation of the screening findings.
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Half of patients with the hormonal disorder, which raises risk of heart attack, stroke and kidney disease, may be undiagnosed under current screening thresholds
Published in the journal Hypertension, a publication of the American Heart Association, the findings suggest that changing the diagnostic threshold for PA would double the detection rate, identifying thousands of high-risk patients who may otherwise be undiagnosed and untreated.
Researchers from Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services, Mass General Brigham, Harvard Medical School and the University of Texas Southwestern Medical School conducted the study, based on deidentified results of lab tests performed by Quest on over 60,449 patients in
Primary aldosteronism occurs when the adrenal glands produce too much aldosterone, a hormone that helps regulate sodium and potassium in the blood. High blood pressure is a defining feature of the condition, though affected individuals may have other common symptoms like headaches or muscle cramps. If left untreated, several complications can occur.
In 2025, the Endocrine Society published guidelines that recommend screening for PA for all patients with high blood pressure and included criteria for diagnosing PA. However, the new study suggests these guidelines are "overly restrictive," with laboratory cutoffs for aldosterone levels that detect only the most advanced cases of the disease. The guideline update also recommends plasma renin activity (PRA), a blood test that measures the conversion of renin in the kidneys, as the initial screening test.
When the researchers applied the 2025 criteria (PRA ≤1 ng/mL/h, aldosterone levels ≥7.5 ng/dL, ARR > 15) to the patient cohort, only
Among patients identified by the more permissive criteria, a PRA score of < 0.5 ng/mL/hr had 1.27 times higher odds of having hypertension compared to those with a higher (or normal) PRA (P < 0.0001). Patients with a PRA of < 0.25 ng/mL/hr had 2.62 times higher odds of having atrial fibrillation (P = 0.0032).
The findings suggest the 2025 guidelines may guide physicians to identify only the more advanced forms of the disease and that primary aldosteronism should be viewed as a spectrum rather than a positive or negative diagnosis of disease. Earlier detection using more relaxed diagnostic criteria may help clinicians identify and intervene with care with potential to prevent long-term cardiovascular complications.
"Our findings demonstrate that current international clinical guidelines for diagnosing primary aldosteronism are optimized to identify advanced disease but may be less sensitive for earlier or milder forms of PA," said lead author Marco Marcelli, MD, a board-certified endocrinologist and Medical Director at Quest Diagnostics. "Some patients with PA spend years on a diagnostic journey before learning their hypertension, headaches and other symptoms are due to a highly treatable condition. More expansive screening and diagnostic criteria may help the medical community to quickly identify these individuals hiding in plain sight before irreversible heart damage and other adverse outcomes have occurred."
The study's strengths include its large patient cohort and its limitations include its retrospective design and lack of confirmatory testing.
Primary aldosteronism is a serious condition that affects as many as 5
About Quest Diagnostics
Quest Diagnostics works across healthcare to create a healthier world, one life at a time. We connect people, from clinicians to consumers, with laboratory insights that illuminate a path to better health. With a focus on delivering smarter, simpler testing, we help reveal new avenues to identify and treat disease, empower healthy behaviors and improve healthcare management. Quest Diagnostics serves half the physicians and hospitals in the United States and one in three American adults each year, and our nearly 60,000 employees work together to deliver diagnostic insights that inspire actions to transform lives. www.QuestDiagnostics.com
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SOURCE Quest Diagnostics
FAQ
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What did the Quest Diagnostics study find about primary aldosteronism screening?
Broader screening criteria identified 26.2% of the cohort as positive for primary aldosteronism, compared with 13.0% under the 2025 Endocrine Society criteria. The retrospective analysis used deidentified Quest laboratory results from over 60,449 U.S. patients and lacked confirmatory testing.
What screening thresholds did the Quest Diagnostics primary aldosteronism study compare?
The broader criteria required plasma renin activity ≤1 ng/mL/h and aldosterone >5 ng/dL, without an aldosterone-to-renin ratio requirement. The 2025 criteria used the same plasma renin activity threshold, aldosterone ≥7.5 ng/dL and an aldosterone-to-renin ratio >15.
Why did the 2025 criteria miss additional patients identified in the Quest Diagnostics study?
79.0% of the additional patients identified by the broader criteria had aldosterone levels between 5 and 7.5 ng/dL, below the Endocrine Society cutoff. Approximately one in five had aldosterone levels meeting the society's criteria but did not meet its aldosterone-to-renin ratio threshold.