Screening for Primary Aldosteronism using Steroids

Steroids-Based Screening for Primary Aldosteronism

This study is testing a new steroid-based method to see if it can better identify Primary Aldosteronism in people with high blood pressure who are taking their usual medications.

Quick facts

• Study type: Observational
• Enrollment: 406 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chongqing Medical University (other)
• Drugs / interventions: prednisone
• Locations: 1 site (Chongqing, Chongqing Municipality)
• Trial ID: NCT06941116 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the effectiveness of a steroid-based screening method for identifying Primary Aldosteronism (PA) in hypertensive patients who are on their usual antihypertensive medications. The study will enroll approximately 515 participants aged 18-75 who have been diagnosed with hypertension and are taking at least one medication that interferes with aldosterone or renin. Participants will undergo testing to compare the steroid-based approach with the conventional aldosterone-to-renin ratio (ARR) method, which often requires medication washout. This approach seeks to improve the accuracy of PA diagnosis while minimizing safety concerns associated with medication changes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with diagnosed hypertension who are currently taking antihypertensive medications that interfere with aldosterone or renin.

Not a fit: Patients with confirmed secondary hypertension from other causes or those with severe cardiac, hepatic, or renal impairment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a more accurate and safer method for diagnosing Primary Aldosteronism in hypertensive patients.

How similar studies have performed: While the approach of using steroid-based screening is innovative, similar studies have not been widely reported, indicating this may be a novel approach.

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.

Where this trial is running

Chongqing, Chongqing Municipality

• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Qifu Li, MD, PhD, Chief Physician — First Affiliated Hospital of Chongqing Medical University
• Study coordinator: Qifu Li, MD, PhD, Chief Physician

Conditions: Primary Aldosteronism, Hypertension, Steroid-Based Screening, Aldosterone-to-Renin Ratio, Machine Learning