The Effect of SAAE on Vascular Endothelial Function in PA Patients

Study Overview
=================
Brief Summary
-----------------
The study aims to assess the effect of superselective adrenal arterial embolization on vascular endothelial function in patients with primary aldosteronism based on brachial artery flow-mediated relaxation

Detailed Description
-----------------
After being informed about the study and potential risks,all patients giving written informed consent will undergo a 2-week screening period to determine eligibility for study entry.At week 0,patients who meet the eligibility requirements will be divided into Superselective adrenal arterial embolization group or spironolactone therapy group,according to the patient's surgical indications and wishes.

Official Title
-----------------
The Effect of Selective Adrenal Artery Embolism on Vascular Endothelial Function in Patients With Primary Aldosteronism Based on Brachial Artery Flow-mediated Relaxation

Conditions
-----------------
Primary Aldosteronism

Intervention / Treatment
-----------------
* Procedure: Super selective adrenal artery embolization
* Drug: Spironolactone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1)Aged 18-75 years, males and females; (2)Blood pressure ≥ 140/90 mmHg on at least three non-same-day office visits without antihypertensive medication or 24-hour ambulatory blood pressure averaging >130/80 mmHg throughout the day or averaging >135/85 mmHg during the day; (3)Primary aldosteronism was diagnosed in accordance with the 2016 international society of Endocrinology clinical guidelines after strict drug elution; (4)Contraindications to spironolactone-free administration; (5)No surgical intention or surgical contraindications, and willing to accept drug treatment or percutaneous superselective adrenal artery embolization; (6)The anatomy of adrenal arteriography is suitable for selective adrenal artery embolization. Exclusion Criteria: (1)Secondary hypertension of other causes; (2)Pregnant women or those who have a fertility plan in the next year; (3)Glomerular filtration rate EGFR < 45 ml/min/1.73m^2; (4)History of severe contrast allergy; (5)Hyperkalemia; (6)Patients with other serious organic diseases or life expectancy < 12 months can not tolerate the treatment of super selective adrenal artery embolizatio; (7)The diameter of adrenal space occupying lesions was more than 2 cm; (8)A history of myocardial infarction, syncope, cerebral hemorrhage or cerebral infarction within 3 months before the informed consent; (9)The results of this study will be affected during the period when patients are enrolled or will participate in other clinical studies.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SAAE group<br>Subjects received super selective adrenal artery embolization treatment | Procedure: Super selective adrenal artery embolization<br>* Superselective adrenal arterial embolization is an operation to inject embolic agent into adrenal artery through catheter to embolize part of adrenal gland, so as to reduce the secretion of adrenal hormone and reduce blood pressure.<br>* Other names: SAAE;|
| Spironolactone group<br>Subjects received spironolactone treatment | Drug: Spironolactone<br>* Aldosterone receptor antagonists are recommended by guidelines for the treatment of bilateral primary aldosteronism.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endothelial function | Brachial artery endothelial function measured by flow-mediated dilation(FMD) | 1 month after SAAE | 
| endothelial function | Brachial artery endothelial function measured by flow-mediated dilation(FMD) | 12 months after SAAE | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PAC | plasma aldosterone concentration | 1 month after SAAE | 
| PAC | plasma aldosterone concentration | 12 months after SAAE | 
| PRA | plasma renin activity | 1 month after SAAE | 
| PRA | plasma renin activity | 12 months after SAAE | 
| ARR | aldosterone-to-renin ratio | 1 month after SAAE | 
| ARR | aldosterone-to-renin ratio | 12 months after SAAE | 
| Serum potassium | Serum potassium | 1 month after SAAE | 
| Serum potassium | Serum potassium | 12 months after SAAE | 
| serum creatinine | serum creatinine | 1 month after SAAE | 
| serum creatinine | serum creatinine | 12 months after SAAE | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
primary aldosteronism, selective adrenal artery embolization, vascular endothelial function