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Development and Validation of a Novel Predictive Model and Comparative Study of Multiple Clinical Prediction Scores for Subtype Differentiation in Primary Aldosteronism: A Prospective Observational Cohort Study Protocol

Development and Validation of a Novel Predictive Model and Comparative Study of Multiple Clinical Prediction Scores for Subtype Differentiation in Primary Aldosteronism: A Prospective Observational Cohort Study Protocol

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500105869
Enrollment
Unknown
Registered
2025-07-14
Start date
2025-07-14
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary aldosteronism

Interventions

Gold Standard:1.The diagnostic criteria for primary aldosteronism (PA) referred to the 2024 Chinese Expert Consensus on the Diagnosis and Management of Primary Aldosteronism recommended by the Chinese
ARR normalization
or aldosterone suppression after a captopril challenge test)..
Index test:Using collected clinical parameters, first screen baseline characteristics significantly associated with aldosterone-producing adenoma for univariate analysis. Prioritize variables previous

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Diagnosis of PA: Patients confirmed to have Primary Aldosteronism by an endocrinologist according to the most recent diagnostic guidelines. 2.Age: >= 18 years. 3.Consent to Participate: Voluntarily agree to participate in the study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients with other forms of secondary hypertension: Such as renal hypertension, renal artery stenosis, Cushing's syndrome, subclinical Cushing's syndrome, hyperthyroidism, hypothyroidism, pheochromocytoma and paraganglioma, congenital adrenal hyperplasia, or other causes of secondary hypertension (e.g., renal hypertension, endocrine hypertension). 2.Severe comorbidities: Such as severe hepatic or renal insufficiency, heart failure, etc. 3.Pregnancy and lactation: Pregnant or lactating women. 4.Other severe diseases: Malignancy, psychiatric disorders, or other conditions potentially affecting the study outcomes.

Design outcomes

Primary

MeasureTime frame
Plasma aldosterone concentration in upright position;Plasma renin concentration in upright position;Change value of aldosterone after postural stimulation test.;Lowest serum potassium;Change value of aldosterone after saline infusion test; Adrenal imaging ;Metabolic score;Change value of aldosterone after captopril test;eGFR;Upright Plasma Direct Renin Concentration (DRC) post-Saline Infusion Test;Upright Plasma Aldosterone Concentration (PAC) post-Saline Infusion Test;Upright Plasma Direct Renin Concentration (DRC) post-Captopril Challenge Test;Upright Plasma Aldosterone Concentration (PAC) post-Captopril Challenge Test;Adrenal Vein Sampling (AVS) Results;CXCR4 Receptor-Targeted Imaging Results;Blood Pressure Measurements at 1/3/6 Months Postoperatively;

Countries

China

Contacts

Public ContactChen Tao

West China Hospital of Sichuan University

chentao@scu.edu.cn+86 189 8060 6758

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026