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

Xinjiang Medical University500 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Primary Aldosteronism Super Selective Adrenal Arterial Embolization

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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;

Outcomes

Primary Outcomes

Complete biochemical cure of PA

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)

Time frame: 6 months post intervention

Complete clinical cure of PA

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).

Time frame: 6 months post intervention

Secondary Outcomes

Changes in ambulatory blood pressure and baseline blood pressure

24-hour ambulatory blood pressure and office systolic and diastolic pressure

Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months

Change of the number of antihypertensive medications

Difference in the change of the number of antihypertensive medications

Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months

Adverse events

Will be directly sought at each study visit through history and physical examination where appropriate Subjects will be encouraged to report between study visits and will have a mechanism to do so Will be classified by system, seriousness, causal relationship and expectedness according to the Common Terminology Criteria for Adverse Events v5.0 (CTCAE)

Time frame: Reported throughout the study period. Approximately 2 years

Readmission rate

Readmission rate, defined as readmission for primary aldosteronism

Time frame: Reported throughout the study period. Approximately 2 years

Change of blood electrolytes (K+, Na +)

Difference in the change of blood electrolytes (K+, Na + in mmol/L)

Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months

Change of plasma aldosterone

Difference in the change of plasma aldosterone (pg/mL)

Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months

Change of plasma cortisol

Difference in the change of plasma cortisol (nmol/L)

Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months

Change of plasma renin measured

Difference in the change of plasma renin (pg/ml)

Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months

Change of liver enzymes

Difference in the change of liver enzymes (ALT, AST in IU/L)

Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months

Change of kidney function

Difference in the change of serum creatinine in umol/L

Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months

Change of fasting blood glucose

Difference in the change of fasting blood glucose in mmol/L

Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months

Change of lipids profiles

Difference in the change of lipids profiles (TC, HDL-C, LDL-C, TG) in mmol/L

Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months

Change of 24-h urine microalbumin

Difference in the change of 24-h urine microalbumin (mg/L)

Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months

Change of 24-h 24-h urine creatinine

Difference in the change of 24-h urine creatinine (umol/L)

Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months

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

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts