Adrenal Venous Sampling Via an Antecubital Approach

Hyperaldosteronism Clinical Trial

— AVSA  

Official title:

Adrenal Venous Sampling Via an Antecubital Approach: A Multicenter Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03778645
• Other study ID #: 2018-995
• Status: Recruiting
• Start date: July 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: December 2018
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Xiongjing Jiang, MD
• Phone: +861088322385
• Email: jxj103[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Currently, adrenal venous sampling (AVS) serves as the gold standard for subtyping of PA. Right adrenal vein catheterization is often difficult due to unfavorable anatomy of the vein including small vein size, short length, caudal direction for the transfemoral approach, and rare drainage to the accessory hepatic vein. All of these factors limit the widespread use of this approach. Given that the right adrenal vein is angled caudally in most patients, AVS via an antecubital approach was performed since January 2012. The purpose of this multicenter retrospective study was to evaluate the safety and feasibility of AVS via the antecubital approach.

Description:

Primary aldosteronism (PA) is recognized as the most common cause of secondary hypertension, with a prevalence of approximately 10% among unselected hypertensive populations. Subtype diagnosis is crucial because unilateral primary aldosteronism can be treated by laparoscopic adrenalectomy or open surgery, which may result in a cure or significant improvement of blood pressure, thus decreases the incidence of cardio-cerebrovascular complications. Currently, adrenal venous sampling (AVS) serves as the gold standard for subtyping of PA. Given that the right adrenal vein is angled caudally in most patients, AVS via an antecubital approach was performed since January 2012 at the Fuwai Hospital. So far, there have been more than fifteen hospitals to have some experience on AVS via antecubital approach with investigators' helps. The purpose of this multicenter retrospective study was to evaluate the safety and feasibility of AVS via the antecubital approach.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Consent of the principal investigator to participate to the data collection of patients with primary aldosteronism underwent AVS via antecubital approach

Exclusion Criteria:

• Refusal of the principal investigator to participate to the AVSA Study

Related Conditions & MeSH terms

• Angiography
• Hyperaldosteronism

Intervention

Procedure:
• Adrenal Venous Sampling
Adrenal Venous Sampling via an Antecubital Approach

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
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	The Second Hospital of Dalian Medical University	Dalian	Liaoning
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	The Eighth Affiliated Hospital of Sun Yat-sen University	Shenzhen	Guangdong
China	The First Affiliated Hospital of Medical College of Shihezi Universtiy	Shihezi	Xinjiang
China	Xi'an NO.3 Hospital	Xi'an	Shanxi
China	Henan Provincial People's Hospital	Zhengzhou	Henan

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 sampling		From January 1st 2012 to December 31st 2018
Secondary	The success rate of right adrenal sampling		From January 1st 2012 to December 31st 2018
Secondary	The success rate of left adrenal sampling		From January 1st 2012 to December 31st 2018
Secondary	The incidence of adrenal vein ruptures occurring during AVS		From January 1st 2012 to December 31st 2018