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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03778645
Other study ID # 2018-995
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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