Actively Recruiting

Age: 18Years - 75Years
All Genders
NCT06941116

Steroids-Based Screening for Primary Aldosteronism

Led by Qifu Li · Updated on 2026-04-28

406

Participants Needed

1

Research Sites

89 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Steroids-Based Screening for Primary Aldosteronism

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 75 years, any gender
  • Diagnosed with hypertension with systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg on at least two different days
  • Currently taking at least one antihypertensive medication that affects aldosterone or renin (ACE inhibitors/ARBs, beta-blockers, dihydropyridine calcium channel blockers, or diuretics including mineralocorticoid receptor antagonists) for at least 4 consecutive weeks
  • Fully informed about the study and willing to provide written consent
Not Eligible

You will not qualify if you...

  • Diagnosed with secondary hypertension from causes other than obstructive sleep apnea, such as renovascular hypertension, renal artery stenosis, reninoma, pheochromocytoma, Cushing's syndrome, or Liddle syndrome
  • Severe heart, liver, or kidney problems or serious infections, including NYHA Class III-IV heart failure, liver enzymes more than 2.5 times normal, estimated glomerular filtration rate below 30 mL/min/1.73 m², diabetic foot, sepsis, pneumonia, or refractory infections
  • History of major cardiovascular or cerebrovascular events within the past 3 months
  • Pregnant or breastfeeding women
  • Taking medications other than specified antihypertensives that affect aldosterone or renin, such as sex hormones, glucocorticoids, NSAIDs, or antipsychotics
  • Lack or restriction of independent decision-making or action capacity
  • History of psychiatric disorders
  • Poor compliance likely to affect study completion

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China, 4000016

Actively Recruiting

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Research Team

Q

Qifu Li, MD, PhD, Chief Physician

CONTACT

S

Shumin Yang, MD, PhD, Chief Physician

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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