Steroids-Based Screening for Primary Aldosteronism

Condition(s) studied

Investigational drug(s) / intervention(s)

Steroid-Based Screening (LC-MS/MS): This diagnostic intervention is a liquid chromatography-tandem mass spectrometry (LC-MS/MS)-based steroid profiling assay. It measures a panel of 18 adrenal steroid hormones (e.g., aldosterone, 18-hydroxycortisol, 18-oxocortisol, corticosterone) from plasma samples. In this study, it is used to screen for Primary Aldosteronism (PA) while patients remain on their usual antihypertensive medications. By comparing these steroid profiles against standard aldosterone-renin measurements, the method aims to reduce the need for medication washout and improve diagnostic accuracy for PA.

Study summary

This prospective, single-center observational study aims to evaluate whether a steroid-based screening method can more accurately identify Primary Aldosteronism (PA) in hypertensive patients who remain on their usual antihypertensive medications, compared with the conventional aldosterone-to-renin ratio (ARR). PA is a common, potentially curable subtype of secondary hypertension that carries increased cardiovascular risk when undiagnosed or untreated. However, current screening protocols recommend "medication washout" or switching to minimally interfering drugs, which may pose safety concerns and add complexity.

In this study, approximately 406 participants (ages 18-75) with diagnosed hypertension and on at least one interfering antihypertensive drug (such as ACE inhibitors, ARBs, beta-blockers, diuretics, or calcium channel blockers) will be enrolled at the Department of Endocrinology, The First Affiliated Hospital of Chongqing Medical University. Each participant will undergo two rounds of blood sampling-first while continuing their usual antihypertensive regimen (the "on-medication" state) and second following a standardized washout/switch period (the "standard state"), if medically feasible. At both stages, levels of plasma aldosterone, renin, and a broad panel of adrenal steroid hormones will be measured by liquid chromatography-tandem mass spectrometry.

By comparing diagnostic performance (e.g., sensitivity, specificity, and area under the receiver operating characteristic curve) of the steroid-based screening versus the ARR, the study seeks to determine whether steroid profiling improves accuracy under real-world treatment conditions. Findings may help refine PA screening strategies, reduce the need for extensive medication adjustments, and contribute to better clinical management of hypertension.

Eligibility

Primary outcome measure(s)

• Diagnostic Accuracy of Steroid-Based Screening vs. ARR for Primary Aldosteronism in Patients on Antihypertensive Medications — From baseline screening while on medication to completion of confirmatory testing, approximately 4-8 weeks.
  The primary outcome is to compare the diagnostic accuracy (e.g., sensitivity, specificity, area under the ROC curve \[AUC\]) of a steroid-based screening approach with the conventional aldosterone-to-renin ratio (ARR) for identifying primary aldosteronism (PA) in participants who remain on interfering antihypertensive medications (ACE inhibitors, ARBs, beta-blockers, diuretics, or calcium channel blockers). Confirmatory tests (e.g., captopril challenge, saline infusion) in a standard (washed-out) state will be used as the reference standard. A higher AUC or better sensitivity/specificity indicates superior performance.

Trial sites (1)

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