Evaluating a new treatment for primary aldosteronism using adrenal artery embolization

The First Affiliated Hospital of Xinjiang Medical University

This study is testing a new treatment called adrenal artery embolization to see if it can help people with primary aldosteronism who can’t take medication or have surgery.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Xinjiang Medical University (Academic / other)
• Locations: 1 site (Ürümqi, Xinjiang)
• Trial ID: NCT06513676 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of adrenal vein blood extraction and super selective adrenal artery embolization (SAAE) for patients with primary aldosteronism. It involves a prospective, multicenter approach to classify types of primary hyperaldosteronism and explore SAAE as a potential treatment alternative for those who cannot tolerate medication or surgery. The study will provide new evidence for the diagnosis and treatment of this condition, promoting the development of SAAE as a viable option.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-60 diagnosed with primary hyperaldosteronism who cannot tolerate medication or surgery.

Not a fit: Patients with severe hypersensitivity to contrast media or other forms of secondary hypertension may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new treatment option for patients with primary aldosteronism who have limited responses to existing therapies.

How similar studies have performed: While the approach of adrenal artery embolization is relatively novel, similar studies have shown promise in treating conditions related to hyperaldosteronism.

Eligibility criteria

Inclusion Criteria:

* Age 18-60 years old;
* Primary hyperaldosteronism was diagnosed in strict accordance with the 2016 International Endocrine Society clinical guidelines;
* Refusal of medication due to adverse reactions, refusal of adrenal resection due to surgical risk, or persistent hyperaldosteronism and cortical insufficiency after adrenal resection;
* The patients and their families were introduced in detail to all the current treatment methods for primary aldosteronism, and the adrenal artery embolization was voluntarily accepted;

Exclusion Criteria:

* A history of severe hypersensitivity to contrast media;
* There are serious complications of liver disease, such as thrombocytopenia, esophageal variceal bleeding, etc;
* Renal insufficiency (serum creatinine \> 176mmol/L or estimated glomerular filtration rate \< min.1.73m2);
* Combined with other secondary hypertension, such as pheochromocytoma, hypercortisolism, renal vascular hypertension (such as renal artery stenosis), renin secretory tumor, renal parenchymatous hypertension, drug-induced hypertension (such as long-term use of glucocorticoids, contraceptives, estrogens, herbs containing glycyrrhizin), pregnancy hypertension and other secondary hypertension;
* Hereditary diseases: such as false aldosteronism (Liddle syndrome), Bartter syndrome, familial hypokalemia and hypomagnesemia (Gitelman syndrome);
* Cerebral apoplexy, myocardial infarction and stent implantation occurred in the past 3 months;
* Serious other basic, such as heart dysfunction (grade IV), acute infection, autoimmune diseases, various malignant tumors and so on;
* Participated in other clinical trials within the past 3 months;
* Individual pregnancy, nursing or planning pregnancy;

Where this trial is running

Ürümqi, Xinjiang

• The First Affiliated Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China (Recruiting)

Study contacts

• Study coordinator: Xiang Xie

Conditions Primary Aldosteronism; Super Selective Adrenal Arterial Embolization