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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05561361
Enrollment
200
Registered
2022-09-30
Start date
2022-10-01
Completion date
2026-12-31
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Aldosteronism

Keywords

primary aldosteronism, selective adrenal artery embolization, vascular endothelial function

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.

Interventions

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.

Sponsors

Second Affiliated Hospital of Nanchang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
endothelial function1 month after SAAEBrachial artery endothelial function measured by flow-mediated dilation(FMD)

Secondary

MeasureTime frameDescription
PAC1 month after SAAEplasma aldosterone concentration
PRA1 month after SAAEplasma renin activity
ARR1 month after SAAEaldosterone-to-renin ratio
Serum potassium1 month after SAAESerum potassium
serum creatinine1 month after SAAEserum creatinine

Countries

China

Contacts

Primary ContactYifei Dong, Doctorate
yf_dong66@126.com+8613576007061

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026