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

Официальное название

The First Affiliated Hospital of Xinjiang Medical University

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Complete biochemical cure of PA [Срок оценки: 6 months post intervention]
• Complete clinical cure of PA [Срок оценки: 6 months post intervention]

Вторичные конечные точки (12)

• Changes in ambulatory blood pressure and baseline blood pressure [Срок оценки: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months]
• Change of the number of antihypertensive medications [Срок оценки: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months]
• Adverse events [Срок оценки: Reported throughout the study period. Approximately 2 years]
• Readmission rate [Срок оценки: Reported throughout the study period. Approximately 2 years]
• Change of blood electrolytes (K+, Na +) [Срок оценки: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months]
• Change of plasma aldosterone [Срок оценки: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months]
• Change of plasma cortisol [Срок оценки: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months]
• Change of plasma renin measured [Срок оценки: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months]
• Change of liver enzymes [Срок оценки: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months]
• Change of kidney function [Срок оценки: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months]
• Change of fasting blood glucose [Срок оценки: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months]
• Change of lipids profiles [Срок оценки: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Xinjiang Medical University — Ürümqi

Идентификаторы

NCT: NCT06513676 · 240528-09

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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