Antecubital Versus Femoral Approach for Adrenal Venous Sampling

NCT ID: NCT06029803

Last Updated: 2023-09-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2023-11-30

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.

Conditions

Hyperaldosteronism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Adrenal Venous Sampling via Antecubital Approach

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

Group Type: EXPERIMENTAL

Adrenal Venous Sampling via Antecubital Approach

Intervention Type: PROCEDURE

Patients assigned to the antecubital approach group (experimental group) will undergo AVS via antecubital approach.A 5F introducer sheath will be introduced into the antecubital vein. After heparinization,a diagnostic catheter with side holes will be introduced. Two blood samples (about 4mL each) will be collected from the inferior vena cava, right adrenal vein and left adrenal vein for the determination of cortisol and aldosterone concentrations.

Adrenal Venous Sampling via Femoral Approach

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

Group Type: ACTIVE_COMPARATOR

Adrenal Venous Sampling via Femoral Approach

Intervention Type: PROCEDURE

Patients assigned to the femoral approach group (active comparator group) will undergo AVS via femoral vein approach.The introducer sheath will be introduced into the femoral vein.Two blood samples (about 4mL each) will be collected from the inferior vena cava, right adrenal vein and left adrenal vein for the determination of cortisol and aldosterone concentrations.

Interventions

Adrenal Venous Sampling via Antecubital Approach

Patients assigned to the antecubital approach group (experimental group) will undergo AVS via antecubital approach.A 5F introducer sheath will be introduced into the antecubital vein. After heparinization,a diagnostic catheter with side holes will be introduced. Two blood samples (about 4mL each) will be collected from the inferior vena cava, right adrenal vein and left adrenal vein for the determination of cortisol and aldosterone concentrations.

Intervention Type: PROCEDURE

Adrenal Venous Sampling via Femoral Approach

Patients assigned to the femoral approach group (active comparator group) will undergo AVS via femoral vein approach.The introducer sheath will be introduced into the femoral vein.Two blood samples (about 4mL each) will be collected from the inferior vena cava, right adrenal vein and left adrenal vein for the determination of cortisol and aldosterone concentrations.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hui DONG

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hui Dong, MD

Role: PRINCIPAL_INVESTIGATOR

Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College

Locations

Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hui Dong, MD

Role: CONTACT

donghui666@sina.com

86-010-88322387

Facility Contacts

Hui Dong, MD

Role: primary

donghui666@sina.com

86-010-88322387

Other Identifiers

2022-1715

Identifier Type: -

Identifier Source: org_study_id