Antecubital Versus Femoral Approach for Adrenal Venous Sampling (AFAVS)

Chinese Academy of Medical Sciences, Fuwai Hospital

Status: Enrolling

Conditions: Hyperaldosteronism

Treatments: Procedure: Adrenal Venous Sampling via Antecubital Approach; Procedure: Adrenal Venous Sampling via Femoral Approach

Study type: Interventional

Funder types: Other

Identifiers

NCT06029803

2022-1715

Details and patient eligibility

About

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.

Full 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.

Enrollment: 154 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged from 18 to 60 with no limits in sex;
2. Patients with confirmed primary aldosteronism;
3. Patients or their legal representatives sign written informed consent approved by the ethics committee

Exclusion criteria

1. Severe comorbidity, including stroke, myocardial infarction, heart failure, severe valvular heart disease, liver cirrhosis, and metastatic tumor within the previous 3 months；
2. An estimated glomerular filtration rate <45 ml/min/1.73 m2, or serum creatinine >176 μmol/L；
3. Patients who refuse adrenalectomy;
4. suspected of having an adrenocortical carcinoma;
5. allergy to contrast agent;
6. pregnant, nursing, or planning to become pregnant

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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154 participants in 2 patient groups

Adrenal Venous Sampling via Antecubital Approach

Experimental group

Description:

Patients in the experimental group will undergo adrenal venous sampling via antecubital vein approach.

Treatment:

Procedure: Adrenal Venous Sampling via Antecubital Approach

Adrenal Venous Sampling via Femoral Approach

Active Comparator group

Description:

Patients in the active comparator group will undergo adrenal venous sampling via femoral vein approach.

Treatment:

Procedure: Adrenal Venous Sampling via Femoral Approach