The Effect of SAAE on Vascular Endothelial Function in PA Patients

Recruiting

• Conditions: Primary Aldosteronism
• Interventions: Procedure: Super selective adrenal artery embolization; Drug: Spironolactone

• Registration Number: NCT05561361
• Lead Sponsor: Second Affiliated Hospital of Nanchang University

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.

Study Timeline

• Study First Submitted: 2022-09-27
• Study First Submitted QC: 2022-09-27
• Study First Posted: 2022-09-30
• Study Start: 2022-10-01
• Status Verified: 2023-09
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17
• Primary Completion: 2026-11-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SAAE group	Super selective adrenal artery embolization	Subjects received super selective adrenal artery embolization treatment
Spironolactone group	Spironolactone	Subjects received spironolactone treatment

Primary Outcome Measures

Name	Time	Method
endothelial function	12 months after SAAE	Brachial artery endothelial function measured by flow-mediated dilation(FMD)

Secondary Outcome Measures

Name	Time	Method
PAC	12 months after SAAE	plasma aldosterone concentration
PRA	12 months after SAAE	plasma renin activity
ARR	12 months after SAAE	aldosterone-to-renin ratio
Serum potassium	12 months after SAAE	Serum potassium
serum creatinine	12 months after SAAE	serum creatinine

Trial Locations

Locations (1)

The Second Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, China