RecruitingNCT06513676

Super Selective Adrenal Artery Embolization for Primary Aldosteronism: a Prospective Cohort Study(SAAE-PA)

The First Affiliated Hospital of Xinjiang Medical University


Sponsor

Xinjiang Medical University

Enrollment

500 participants

Start Date

Apr 15, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

The objective of this study was to evaluate the efficacy and safety of adrenal vein blood extraction for primary aldosteronism classification and adrenal artery embolization in the treatment of primary aldosteronism, to provide new evidence plan for the diagnosis and treatment of primary aldosteronism, and to promote the development of adrenal artery embolization as a new treatment for primary aldosteronism.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria4

  • 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 Criteria9

  • 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;

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Locations(1)

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

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NCT06513676


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