Targeted adrenal artery embolization versus oral spironolactone for idiopathic hyperaldosteronism
A Prospective Randomized Controlled Trial for Treatment of Idiopathic Hyperaldosteronism: Superselective Adrenal Arterial Embolization Versus Oral Spironolactone
This trial will test whether a minimally invasive targeted adrenal artery embolization works as well as the oral drug spironolactone for people aged 15–60 with idiopathic hyperaldosteronism.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 172 (estimated) |
| Ages | 15 Years to 60 Years |
| Sex | All |
| Sponsor | Chinese Academy of Medical Sciences, Fuwai Hospital Academic / other |
| Locations | 3 sites (Beijing, Beijing Municipality and 2 other locations) |
| Trial ID | NCT07328230 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: People aged 15–60 diagnosed with idiopathic hyperaldosteronism (bilateral adrenal hyperplasia) who meet the 2016 Endocrine Society criteria and can consent and tolerate endovascular treatment are ideal candidates.
Not a fit: Patients with unilateral adrenal disease, eGFR below 45 ml/min/1.73 m² or serum creatinine above 176 µmol/L, recent stroke/myocardial infarction or stent, severe contrast allergy, pregnancy, other serious comorbidities, or other forms of secondary hypertension are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, SAAE could provide a minimally invasive option that lowers aldosterone and blood pressure while reducing long-term medication side effects and improving adherence.
How similar studies have performed: SAAE has been used clinically over the past decade with promising case series and observational reports, but high-quality randomized comparisons against MRAs are scarce.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing, Beijing Municipality and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.