The Effect of SAAE on Vascular Endothelial Function in PA Patients

• Sponsor: Second Affiliated Hospital of Nanchang University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05561361
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Anticipated Duration (Months): 22
• Patients Per Site Per Month: 9.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Primary Aldosteronism	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 Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: Jan 31, 2024
• Anticipated Study Completion Date: Jul 31, 2024

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. endothelial function [1 month after SAAE]

   Brachial artery endothelial function measured by flow-mediated dilation(FMD)

2. endothelial function [12 months after SAAE]

   Brachial artery endothelial function measured by flow-mediated dilation(FMD)

Secondary Outcome Measures

1. PAC [1 month after SAAE]

   plasma aldosterone concentration

2. PAC [12 months after SAAE]

   plasma aldosterone concentration

3. PRA [1 month after SAAE]

   plasma renin activity

4. PRA [12 months after SAAE]

   plasma renin activity

5. ARR [1 month after SAAE]

   aldosterone-to-renin ratio

6. ARR [12 months after SAAE]

   aldosterone-to-renin ratio

7. Serum potassium [1 month after SAAE]

   Serum potassium

8. Serum potassium [12 months after SAAE]

   Serum potassium

9. serum creatinine [1 month after SAAE]

   serum creatinine

10. serum creatinine [12 months after SAAE]

    serum creatinine

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Second Affiliated Hospital of Nanchang University	Nanchang		China

Sponsors and Collaborators

• Second Affiliated Hospital of Nanchang University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Second Affiliated Hospital of Nanchang University
• ClinicalTrials.gov Identifier: NCT05561361
• Other Study ID Numbers: IIT-O-2021-032
• First Posted: Sep 30, 2022
• Last Update Posted: Dec 14, 2022
• Last Verified: Sep 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Second Affiliated Hospital of Nanchang University: primary aldosteronism; selective adrenal artery embolization; vascular endothelial function
• Additional relevant MeSH terms: Hyperaldosteronism; Spironolactone

Study Results

No Results Posted as of Dec 14, 2022