RecruitingNCT05561361

The Effect of SAAE on Vascular Endothelial Function in PA Patients

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


Sponsor

Second Affiliated Hospital of Nanchang University

Enrollment

200 participants

Start Date

Oct 1, 2022

Study Type

OBSERVATIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

  • (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 Criteria9

  • (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.

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Interventions

PROCEDURESuper selective adrenal artery embolization

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.

DRUGSpironolactone

Aldosterone receptor antagonists are recommended by guidelines for the treatment of bilateral primary aldosteronism.


Locations(1)

The Second Affiliated Hospital of Nanchang University

Nanchang, China

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NCT05561361


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