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

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

Study Overview

• Status: Recruiting
• Conditions: Primary Aldosteronism
• Intervention / Treatment: Procedure: Super selective adrenal artery embolization; Drug: Spironolactone

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Yifei Dong, doctorate; Phone Number: +8613576007061; Email: yf_dong66@126.com

Study Locations

• China
  • Nanchang, China
    • Recruiting
    • The Second Affiliated Hospital of Nanchang University
    • Contact: Yifei Dong, doctorate; Phone Number: +8613576007061; Email: yf_dong66@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SAAE group; Subjects received super selective adrenal artery embolization treatment	Procedure: 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.; Other Names: SAAE
Spironolactone group; Subjects received spironolactone treatment	Drug: Spironolactone; Aldosterone receptor antagonists are recommended by guidelines for the treatment of bilateral primary aldosteronism.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
endothelial function	Brachial artery endothelial function measured by flow-mediated dilation(FMD)	1 month after SAAE
endothelial function	Brachial artery endothelial function measured by flow-mediated dilation(FMD)	12 months after SAAE

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PAC	plasma aldosterone concentration	1 month after SAAE
PAC	plasma aldosterone concentration	12 months after SAAE
PRA	plasma renin activity	1 month after SAAE
PRA	plasma renin activity	12 months after SAAE
ARR	aldosterone-to-renin ratio	1 month after SAAE
ARR	aldosterone-to-renin ratio	12 months after SAAE
Serum potassium	Serum potassium	1 month after SAAE
Serum potassium	Serum potassium	12 months after SAAE
serum creatinine	serum creatinine	1 month after SAAE
serum creatinine	serum creatinine	12 months after SAAE

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Nanchang University
• Investigators: Study Director: Yifei Dong, Second Affiliated Hospital of Nanchang University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 27, 2022
• First Submitted That Met QC Criteria: September 27, 2022
• First Posted (Actual): September 30, 2022

Study Record Updates

• Last Update Posted (Estimated): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 7, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: primary aldosteronism; vascular endothelial function; selective adrenal artery embolization
• Additional Relevant MeSH Terms: Endocrine System Diseases; Adrenal Gland Diseases; Adrenocortical Hyperfunction; Hyperaldosteronism; Organic Chemicals; Polycyclic Compounds; Pregnanes; Steroids; Fused-Ring Compounds; Lactones; Pregnenes; Spironolactone
• Other Study ID Numbers: IIT-O-2021-032

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No