The Effect of SAAE on Vascular Endothelial Function in PA Patients

Nanchang University

Status

Enrolling

Conditions

Primary Aldosteronism

Treatments

Drug: Spironolactone

Procedure: Super selective adrenal artery embolization

Study type

Observational

Funder types

Other

Identifiers

NCT05561361

IIT-O-2021-032

Details and patient eligibility

About

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

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.