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NCT Number: NCT06941116

Steroids-Based Screening for Primary Aldosteronism

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.

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Key information

Conditions

Primary Aldosteronism Adrenal Gland Diseases Adrenocortical Hyperfunction Cardiovascular Diseases Endocrine System Diseases Hyperaldosteronism Hypertension Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 4000016, China

Location status: Recruiting

Location contact

Jinbo Hu, MD, PhD

PRINCIPAL_INVESTIGATOR

Qifu Li, MD, PhD, Chief Physician

PRINCIPAL_INVESTIGATOR

Shili Peng

CONTACT

[email protected]

+8613689092519

Shumin Yang, MD, PhD, Chief Physician

PRINCIPAL_INVESTIGATOR

Yixin Zhang, MD

CONTACT

[email protected]

+8618716816738

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18-75 years, with no sex restriction.
  • Diagnosed with hypertension, defined as a systolic blood pressure ≥140 mmHg and/or a diastolic blood pressure ≥90 mmHg measured on at least two different days.
  • Currently receiving at least one antihypertensive medication that interferes with aldosterone or renin (ACEI/ARB, β-blockers, dihydropyridine CCBs, or diuretics including MRA) for ≥4 consecutive weeks.
  • Fully informed about the study procedures and risks, and willing to participate by signing a written informed consent form.

Exclusion criteria

  • Confirmed secondary hypertension of other etiologies (e.g., renovascular hypertension, renal artery stenosis, reninoma, pheochromocytoma, Cushing's syndrome, Liddle syndrome), excluding obstructive sleep apnea.
  • Severe cardiac, hepatic, or renal impairment or serious infections, including but not limited to New York Heart Association (NYHA) Class III-IV heart failure, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels exceeding 2.5 times the upper limit of normal, estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m², or severe infections (e.g., diabetic foot, sepsis, pneumonia, refractory infections).
  • History of major cardiovascular or cerebrovascular events within the past 3 months.
  • Pregnant or breastfeeding women.
  • Currently using medications (other than the listed antihypertensives) that may affect aldosterone or renin secretion, including but not limited to sex hormones (e.g., oral contraceptives, estrogen replacement therapy), glucocorticoids (e.g., prednisone, dexamethasone), nonsteroidal anti-inflammatory drugs (NSAIDs, e.g., aspirin, ibuprofen), or antipsychotics (e.g., chlorpromazine, olanzapine).
  • Individuals lacking or having restricted capacity for independent decision-making or action.
  • History of psychiatric disorders.
  • Poor compliance likely to compromise study completion.

Treatment and study plan

Steroid-Based Screening (LC-MS/MS)

Diagnostic Test

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.

Primary outcomes

  1. Diagnostic Accuracy of Steroid-Based Screening vs. ARR for Primary Aldosteronism in Patients on Antihypertensive Medications

    Time frame: 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.

Other outcomes

  1. Prospective validation of steroid profiling-derived biomarkers and combined strategies for unilateral primary aldosteronism

    Time frame: From enrollment through completion of subtype classification, up to March 2026

    Among patients with subtype-confirmed primary aldosteronism, this outcome will assess the diagnostic performance of candidate biomarkers derived from steroid profiling and combined strategies, including approaches integrating adrenal imaging features, for identifying unilateral primary aldosteronism.

Study contacts

Contact information is provided by the study sponsor or research team.

Qifu Li, MD, PhD, Chief Physician

CONTACT

[email protected]

+8618696676815 ext. 023-89011554

Shumin Yang, MD, PhD, Chief Physician

CONTACT

[email protected]

‭+8615523552235‬ ext. 023-89011554

Sponsors and collaborators

Lead sponsor

Qifu Li

Other

Registry information

Acronym: SAFE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 23, 2025
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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