Status:
RECRUITING
Steroids-Based Screening for Primary Aldosteronism
Lead Sponsor:
Qifu Li
Conditions:
Primary Aldosteronism
Hypertension
Eligibility:
All Genders
18-75 years
Brief 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 remai...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 15 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
515 Patients enrolled
Trial Details
Trial ID
NCT06941116
Start Date
April 15 2025
End Date
December 30 2026
Last Update
April 23 2025
Active Locations (1)
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1
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 4000016