Clinical trial NCT05561361: The Effect of SAAE on Vascular Endothelial Function in PA Patients
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Aldosteronism
Keywords: primary aldosteronism
selective adrenal artery embolization
vascular endothelial function
Lead sponsor: Second Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2022-09-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were diagnosed with primary aldosteronism and underwent adrenal vein sampling at the Second Affiliated Hospital of Nanchang University.

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.

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.

Primary outcomes:
measure: endothelial function
timeFrame: 1 month after SAAE
measure: endothelial function
timeFrame: 12 months after SAAE
Secondary outcomes:
measure: PAC
timeFrame: 1 month after SAAE
measure: PAC
timeFrame: 12 months after SAAE
measure: PRA
timeFrame: 1 month after SAAE
measure: PRA
timeFrame: 12 months after SAAE
measure: ARR
timeFrame: 1 month after SAAE
measure: ARR
timeFrame: 12 months after SAAE
measure: Serum potassium
timeFrame: 1 month after SAAE
measure: Serum potassium
timeFrame: 12 months after SAAE
measure: serum creatinine
timeFrame: 1 month after SAAE
measure: serum creatinine
timeFrame: 12 months after SAAE
Other outcomes:
Locations:
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
Study officials:
affiliation: Second Affiliated Hospital of Nanchang University
name: Yifei Dong
role: STUDY_DIRECTOR
References: