RecruitingNCT06941116

Steroids-Based Screening for Primary Aldosteronism


Sponsor

Qifu Li

Enrollment

406 participants

Start Date

Apr 15, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new steroid-based blood test to screen for primary aldosteronism — a common but often missed cause of high blood pressure where the adrenal gland produces too much aldosterone hormone. **You may be eligible if...** - You are aged 18–75 - You have high blood pressure (hypertension) confirmed on at least two separate days - You are currently taking at least one blood pressure medication (such as an ACE inhibitor, ARB, beta-blocker, or diuretic) for at least 4 consecutive weeks **You may NOT be eligible if...** - You have already been diagnosed with another cause of secondary hypertension (such as pheochromocytoma or Cushing's syndrome) - You have severe heart failure, liver disease, or kidney impairment - You are pregnant or breastfeeding - You have recently had a serious cardiovascular event Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTSteroid-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.


Locations(1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

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NCT06941116


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