Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT06029803
Status:
UNKNOWN
Last Update Posted:
2023-09-08
First Post:
2023-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Antecubital Versus Femoral Approach for Adrenal Venous Sampling
Sponsor:
Chinese Academy of Medical Sciences, Fuwai Hospital
Organization:
Study Overview
Official Title:
Antecubital Versus Femoral Approach for Adrenal Venous Sampling: A Randomised Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2023-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AFAVS
Brief Summary:
Subtype diagnosis is crucial for the treatment of primary aldosteronism (PA), which conducts the appropriate treatment strategy. Currently, adrenal venous sampling (AVS) serves as the gold standard for subtyping of PA. At present, almost all medical centers use the femoral vein approach for AVS, and most studies report that the success rate is 30%-80%. Our research team is the first in the world to conduct AVS via an antecubital approach. The aim of this study is to compare the success rate and safety of AVS via antecubital and femoral approach.
Detailed Description:
Primary aldosteronism (PA) is one of the most common causes of secondary hypertension, and its most common subtypes are aldosterone-producing adenoma and idiopathic hyperaldosteronism, which account for 95% to 98% of PA. Subtype diagnosis is crucial for the treatment of primary aldosteronism, which conducts the appropriate treatment strategy. Currently, adrenal venous sampling (AVS) serves as the gold standard for subtyping of PA. At present, almost all medical centers use the femoral vein approach for AVS, and most studies report that the success rate is 30%-80%.How to improve the success rate of AVS has been a hot topic in the field of primary aldosteronism. Our research team is the first in the world to conduct AVS via an antecubital approach. The previous study found that the success rate of AVS via this approach can reach to 88.0%, with a low incidence of complications. In this study, patients with primary aldosteronism who meet the indications of AVS will be randomly assigned to antecubital approach group and femoral approach group. Clinical, laboratory and examination data will be recorded and the success rate and safety of AVS via antecubital and femoral approach will be compared.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: