Antecubital Versus Femoral Approach for Adrenal Venous Sampling

NCT06029803 | Unknown

• 1 other identifier: 2022-1715
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperaldosteronism

Keywords

Adrenal venous sampling; Hyperaldosteronism; Antecubital approach; Femoral approach

Outcome Measures

Primary Outcomes (1)

• The success rate of bilateral adrenal venous sampling

  Successful sampling will be defined by high selectivity index (cortisol in the adrenal vein/cortisol in inferior vena cava \>2 without ACTH simulation)

  At AVS procedure

Secondary Outcomes (8)

• The success rate of left adrenal venous sampling

  At AVS procedure

• The success rate of right adrenal venous sampling

  At AVS procedure

• Selection of intraoperative catheter

  At AVS procedure

• Time of the procedure

  At AVS procedure

• Time of fluoroscopy

  At AVS procedure

Study Arms (2)

Adrenal Venous Sampling via Antecubital Approach

EXPERIMENTAL

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

Procedure: Adrenal Venous Sampling via Antecubital Approach

Adrenal Venous Sampling via Femoral Approach

ACTIVE COMPARATOR

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

Procedure: Adrenal Venous Sampling via Femoral Approach

Interventions

Adrenal Venous Sampling via Antecubital Approach 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 Antecubital Approach

Adrenal Venous Sampling via Femoral Approach 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.

Adrenal Venous Sampling via Femoral Approach

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Hui Dong, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Dong, MD

CONTACT

86-010-88322387; donghui666@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 26, 2023
• First Posted: September 8, 2023
• Study Start: April 1, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-09

Locations

CN (1)