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NCT Number: NCT05561361

The Effect of SAAE on Vascular Endothelial Function in PA Patients

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Nanchang University

Nanchang, China

Location status: Recruiting

Location contact

Yifei Dong, doctorate

CONTACT

[email protected]

+8613576007061

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Super selective adrenal artery embolization

Procedure

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.

Other names: SAAE

Spironolactone

Drug

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

Primary outcomes

  1. endothelial function

    Time frame: 1 month after SAAE

    Brachial artery endothelial function measured by flow-mediated dilation(FMD)

  2. endothelial function

    Time frame: 12 months after SAAE

    Brachial artery endothelial function measured by flow-mediated dilation(FMD)

Secondary outcomes

  1. PAC

    Time frame: 1 month after SAAE

    plasma aldosterone concentration

  2. PAC

    Time frame: 12 months after SAAE

    plasma aldosterone concentration

  3. PRA

    Time frame: 1 month after SAAE

    plasma renin activity

  4. PRA

    Time frame: 12 months after SAAE

    plasma renin activity

  5. ARR

    Time frame: 1 month after SAAE

    aldosterone-to-renin ratio

  6. ARR

    Time frame: 12 months after SAAE

    aldosterone-to-renin ratio

  7. Serum potassium

    Time frame: 1 month after SAAE

    Serum potassium

  8. Serum potassium

    Time frame: 12 months after SAAE

    Serum potassium

  9. serum creatinine

    Time frame: 1 month after SAAE

    serum creatinine

  10. serum creatinine

    Time frame: 12 months after SAAE

    serum creatinine

Study contacts

Contact information is provided by the study sponsor or research team.

Yifei Dong, Doctorate

CONTACT

[email protected]

+8613576007061

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Nanchang University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Sep 30, 2022
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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