Steroids-Based Screening for Primary Aldosteronism

Launched by QIFU LI · Apr 16, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new way to screen for Primary Aldosteronism (PA), a condition that can cause high blood pressure and is treatable if identified early. The study aims to see if a steroid-based screening method can better identify PA in patients who are already taking medications for their hypertension, compared to the standard screening method which requires stopping these medications. Approximately 515 adults aged 18 to 75 with high blood pressure who are on specific medications will participate. This includes individuals taking drugs like ACE inhibitors, beta-blockers, or diuretics.

Participants will provide blood samples at two different times: once while continuing their regular medications and again after a period of switching medications, if it's safe to do so. The study hopes to find out if this new screening method offers better accuracy without needing to make significant changes to patients' medication routines. This could lead to improved detection of PA and better management of high blood pressure for patients. If you have high blood pressure and meet the eligibility criteria, you may be able to join this study and contribute to advancing our understanding of this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 18-75 years, with no sex restriction.
• • 2. 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.
• • 3. 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.
• • 4. Fully informed about the study procedures and risks, and willing to participate by signing a written informed consent form.
• Exclusion Criteria:
• • 1. Confirmed secondary hypertension of other etiologies (e.g., renovascular hypertension, renal artery stenosis, reninoma, pheochromocytoma, Cushing's syndrome, Liddle syndrome), excluding obstructive sleep apnea.
• • 2. 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).
• • 3. History of major cardiovascular or cerebrovascular events within the past 3 months.
• • 4. Pregnant or breastfeeding women.
• • 5. 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).
• • 6. Individuals lacking or having restricted capacity for independent decision-making or action.
• • 7. History of psychiatric disorders.
• • 8. Poor compliance likely to compromise study completion.