The Effect of SAAE on Vascular Endothelial Function in PA Patients

NCT ID: NCT05561361

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-01

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Primary Aldosteronism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SAAE group

Subjects received super selective adrenal artery embolization treatment

Super selective adrenal artery embolization

Intervention Type 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.

Spironolactone group

Subjects received spironolactone treatment

Spironolactone

Intervention Type DRUG

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

Interventions

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Super 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.

Intervention Type PROCEDURE

Spironolactone

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

Intervention Type DRUG

Other Intervention Names

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SAAE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital of Nanchang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yifei Dong

Role: STUDY_DIRECTOR

Second Affiliated Hospital of Nanchang University

Locations

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The Second Affiliated Hospital of Nanchang University

Nanchang, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yifei Dong, Doctorate

Role: CONTACT

+8613576007061

Facility Contacts

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Yifei Dong, doctorate

Role: primary

+8613576007061

Other Identifiers

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IIT-O-2021-032

Identifier Type: -

Identifier Source: org_study_id

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