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
Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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;
Primary outcome measure(s)
Complete biochemical cure of PA — 6 months post intervention Complete biochemical cure of PA, defined (whilst off medications that might alter serum potassium or the RAS) by both:
1. Normalisation of serum potassium, and
2. Normalisation of ARR, or
3. Elevated ARR and i). Baseline PAC \<190pmol/L, or ii). Normal confirmatory test (as defined in the inclusion criteria)
Complete clinical cure of PA — 6 months post intervention Complete clinical cure of PA, defined as normotension without antihypertensive medication
These criteria have been defined in the international consensus PASO statement8, which has become the established yardstick by which PA cure is judged. In this, normotension is defined, in accordance with the European Society of Hypertension guidelines22, as \<140/80 in the office, \<135/85 at home or daytime ambulatory monitoring and \<130/80 for 24h ambulatory blood pressure monitoring (24hABPM).
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Xinjiang Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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