Targeted adrenal artery embolization versus oral spironolactone for idiopathic hyperaldosteronism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial compares superselective adrenal artery embolization (SAAE) to standard medical treatment with spironolactone in patients with idiopathic hyperaldosteronism due to bilateral adrenal hyperplasia. SAAE is a minimally invasive endovascular procedure that embolizes terminal branches of the adrenal arteries to reduce aldosterone production while preserving cortical tissue. Participants meeting endocrine diagnostic criteria are randomized to receive either SAAE or spironolactone and are followed for safety, blood pressure control, biochemical remission, and adverse events. The trial is multicenter, conducted at major cardiovascular and endocrine hospitals in China, and excludes patients with unilateral disease, significant renal impairment, recent major cardiovascular events, contrast allergy, pregnancy, or other secondary hypertension.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged from 15 to 60 with no limits in sex;
2. Patients are diagnosed with primary aldosteronism according to the criteria of the 2016 Endocrine Society guidelines;
3. Sub-typing diagnosis confirmed idiopathic hyperaldosteronism;
4. Patients or their legal representatives have to sign written informed consent approved by the ethics committee.

Exclusion Criteria:

1. Unilateral adrenal hyperplasia;
2. Renal insufficiency with an estimated glomerular filtration rate (based on the modification of diet in renal disease criteria) \<45 ml/min/1.73 m², and/or serum creatinine \>176 μmol/L；
3. Hemorrhagic or ischemic stroke, endovascular stent implantation and myocardial infarction within the previous 3 months;
4. Severe contrast agent allergy;
5. Women who are pregnant or planning to become pregnant;
6. Patients with other serious organic diseases cannot tolerate SAAE treatment;
7. Other forms of secondary hypertension.

Where it's running

• Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
  Beijing, Beijing Municipality, China Recruiting
• Second Affiliated Hospital of Nanchang University
  Nanchang, Jiangxi, China Recruiting
• The First Affiliated Hospital of Chengdu Medical College
  Chengdu, Sichuan, China Recruiting

Study contacts

• Principal investigator: Xiongjing Jiang, MD — Fuwai Hospital, National Center for Cardiovascular Disease
• Study coordinator: Xiongjing Jiang, MD
• Email: jxj103@hotmail.com
• Phone: 86-010-88322387

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Understanding primary aldosteronism in patients from Western Norway

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.