Antecubital Versus Femoral Approach for Adrenal Venous Sampling

Not Applicable

Recruiting

• Conditions: Hyperaldosteronism
• Interventions: Procedure: Adrenal Venous Sampling via Antecubital Approach; Procedure: Adrenal Venous Sampling via Femoral Approach

• Registration Number: NCT06029803
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

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 Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2023-08-26
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-01
• Last Update Submitted: 2023-09-01
• Study First Posted: 2023-09-08
• Last Update Posted: 2023-09-08
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 154

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adrenal Venous Sampling via Antecubital Approach	Adrenal Venous Sampling via Antecubital Approach	Patients in the experimental group will undergo adrenal venous sampling via antecubital vein approach.
Adrenal Venous Sampling via Femoral Approach	Adrenal Venous Sampling via Femoral Approach	Patients in the active comparator group will undergo adrenal venous sampling via femoral vein approach.

Primary Outcome Measures

Name	Time	Method
The success rate of bilateral adrenal venous sampling	At AVS procedure	Successful sampling will be defined by high selectivity index (cortisol in the adrenal vein/cortisol in inferior vena cava \>2 without ACTH simulation)

Secondary Outcome Measures

Name	Time	Method
the incidence of complications	1 week after AVS procedure	Complications related to adrenal vein cannulations (adrenal vein hematoma, inferior vena cava dissection, puncture site hematoma, etc)
The success rate of left adrenal venous sampling	At AVS procedure	Successful sampling will be defined by high selectivity index (cortisol in the adrenal vein/cortisol in inferior vena cava \>2 without ACTH simulation)
Selection of intraoperative catheter	At AVS procedure	Catheter selection
The contrast agent dosage	At AVS procedure	The contrast agent dosage
The success rate of right adrenal venous sampling	At AVS procedure	Successful sampling will be defined by high selectivity index (cortisol in the adrenal vein/cortisol in inferior vena cava \>2 without ACTH simulation)
Time of fluoroscopy	At AVS procedure	Time of fluoroscopy
the cost of the procedure	At AVS procedure	the cost of the procedure
Time of the procedure	At AVS procedure	Time of the procedure

Trial Locations

Locations (1)

Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, Beijing, China