Clinical trial NCT06513676: Super Selective Adrenal Artery Embolization for Primary Aldosteronism: a Prospective Cohort Study(SAAE-PA)
Official title: The First Affiliated Hospital of Xinjiang Medical University
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Aldosteronism
Super Selective Adrenal Arterial Embolization
Lead sponsor: Xinjiang Medical University
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hypertensive patients were willing to participate and then hospitalized for further evaluation. Antihypertensive medications that affect the renin-angiotensin-aldosterone system were stopped for two weeks, diuretics and MRA were withdrawn for at least 4 weeks before ARR testing. Hypertensive patients were prescribed with verapamil and/or terazosin based on Endocrine Society Clinical Practice Guideline. Patients with positive aldosterone-to-renin ratio underwent one of the following confirmatory tests: saline infusion test or captopril inhibition test. Adrenal CT scan and adrenal venous sampling (AVS) were performed for subtype classification of the PA. The PA patients were counseled on the various treatment options, including surgery, medications, and adrenal artery ablation.

Brief 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.

Detailed description: As one of the causes of refractory secondary hypertension, primary aldosteronism is usually treated with drug therapy and adrenalectomy, but the therapeutic effect of these regimens is limited in some people. Adrenal vein blood collection is a method to identify the types of primary hyperaldosteronism by comparing the ratio of aldosterone in venous blood by selective catheterization into adrenal vein. Superselective adrenal artery embolization is a catheter-based percutaneous cavitary procedure in which ethanol is selectively injected into the adrenal artery to ablate part of the adrenal gland. Recently, it has been used as an alternative therapy for patients with unilateral aldosterone-producing adenomas as well as idiopathic hyperaldosteronism without obvious adenomas. This is a prospective, multicenter, randomized controlled study in Xinjiang to explore the potential of SAAE as a treatment.

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;

Primary outcomes:
measure: Complete biochemical cure of PA
timeFrame: 6 months post intervention
measure: Complete clinical cure of PA
timeFrame: 6 months post intervention
Secondary outcomes:
measure: Changes in ambulatory blood pressure and baseline blood pressure
timeFrame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
measure: Change of the number of antihypertensive medications
timeFrame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
measure: Adverse events
timeFrame: Reported throughout the study period. Approximately 2 years
measure: Readmission rate
timeFrame: Reported throughout the study period. Approximately 2 years
measure: Change of blood electrolytes (K+, Na +)
timeFrame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
measure: Change of plasma aldosterone
timeFrame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
measure: Change of plasma cortisol
timeFrame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
measure: Change of plasma renin measured
timeFrame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
measure: Change of liver enzymes
timeFrame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
measure: Change of kidney function
timeFrame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
measure: Change of fasting blood glucose
timeFrame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
measure: Change of lipids profiles
timeFrame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
measure: Change of 24-h urine microalbumin
timeFrame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
measure: Change of 24-h 24-h urine creatinine
timeFrame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Other outcomes:
Locations:
city: Ürümqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
Study officials:
References: