Antecubital Versus Femoral Approach for Adrenal Venous Sampling

Hyperaldosteronism Clinical Trial

— AFAVS  

Official title:

Antecubital Versus Femoral Approach for Adrenal Venous Sampling: A Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06029803
• Other study ID #: 2022-1715
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: September 2023
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Hui Dong, MD
• Phone: 86-010-88322387
• Email: donghui666[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperaldosteronism

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
China	Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The success rate of left 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	The success rate of right 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	Selection of intraoperative catheter	Catheter selection	At AVS procedure
Secondary	Time of the procedure	Time of the procedure	At AVS procedure
Secondary	Time of fluoroscopy	Time of fluoroscopy	At AVS procedure
Secondary	The contrast agent dosage	The contrast agent dosage	At AVS procedure
Secondary	the incidence of complications	Complications related to adrenal vein cannulations (adrenal vein hematoma, inferior vena cava dissection, puncture site hematoma, etc)	1 week after AVS procedure
Secondary	the cost of the procedure	the cost of the procedure	At AVS procedure