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A Prospective, Randomized, Controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Surgical Treatment for Idiopathic Hyperaldosteronism

A Prospective, Randomized, Controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Surgical Treatment for Idiopathic Hyperaldosteronism

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128970
Enrollment
Unknown
Registered
2026-07-29
Start date
2026-09-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Idiopathic Hyperaldosteronism, IHA

Interventions

Surgical group:Patients will undergo surgical treatment.
Pharmacological group:Patients will initiate standard mineralocorticoid receptor antagonist (MRA) therapy, with spironolactone or eplerenone as the foundation. The dosage will be adjusted according to

Sponsors

Beijing Anzhen Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 or older, any gender; 2. Patients clinically diagnosed with PA, diagnosed based on an elevated plasma aldosterone/renin ratio (ARR), positive saline infusion test, or positive captopril test; after completing [18F]AlF-NOTA-Pentixather PET/CT scans, all patients should undergo medication washout during screening and AVS; 3. Imaging (thin-slice adrenal CT or MRI) suggests: normal bilateral adrenal morphology, bilateral diffuse hyperplasia, or bilateral small nodules (maximum diameter < 1.0 cm); 4. Surgical group can include IHA patients intolerant to medication or with significant side effects, or patients with a strong personal desire for surgery; 5. Patients who can understand the study, voluntarily participate, and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Imaging shows a clear unilateral adrenal adenoma (diameter >= 1.0 cm); 2. Other definite causes of secondary hypertension (e.g., renal artery stenosis); 3. Severe heart, liver, or cerebrovascular disease, or surgical contraindications making surgery or anesthesia intolerable; 4. Severe renal dysfunction; 5. Pregnant or breastfeeding women, or women planning to become pregnant during the study; 6. Suspected or confirmed adrenal cortical carcinoma or pheochromocytoma; 7. Unable to comply with long-term follow-up; 8. Currently participating in other clinical trials; 9. History of prior adrenal surgery.

Design outcomes

Primary

MeasureTime frame
aldosterone;Clinical effective remission rate at 12 months;

Secondary

MeasureTime frame
renin;serum potassium;blood pressure;

Countries

China

Contacts

Public ContactNing Zhang

Beijing Anzhen Hospital, Capital Medical University

niru7429@126.com+86 10 8819 6064

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026