The Effect of SAAE on Vascular Endothelial Function in PA Patients

Primary Aldosteronism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05561361
• Other study ID #: IIT-O-2021-032
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: September 2023
• Source: Second Affiliated Hospital of Nanchang University
• Contact: Yifei Dong, Doctorate
• Phone: +8613576007061
• Email: yf_dong66[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2026
• Est. primary completion date: November 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperaldosteronism
• Primary Aldosteronism

Intervention

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.

Drug:
• Spironolactone
Aldosterone receptor antagonists are recommended by guidelines for the treatment of bilateral primary aldosteronism.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Nanchang University	Nanchang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Nanchang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endothelial function	Brachial artery endothelial function measured by flow-mediated dilation(FMD)	1 month after SAAE
Primary	endothelial function	Brachial artery endothelial function measured by flow-mediated dilation(FMD)	12 months after SAAE
Secondary	PAC	plasma aldosterone concentration	1 month after SAAE
Secondary	PAC	plasma aldosterone concentration	12 months after SAAE
Secondary	PRA	plasma renin activity	1 month after SAAE
Secondary	PRA	plasma renin activity	12 months after SAAE
Secondary	ARR	aldosterone-to-renin ratio	1 month after SAAE
Secondary	ARR	aldosterone-to-renin ratio	12 months after SAAE
Secondary	Serum potassium	Serum potassium	1 month after SAAE
Secondary	Serum potassium	Serum potassium	12 months after SAAE
Secondary	serum creatinine	serum creatinine	1 month after SAAE
Secondary	serum creatinine	serum creatinine	12 months after SAAE