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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05561361
Other study ID # IIT-O-2021-032
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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