Clinical trial NCT06192238: China National Study of Adrenal Venous Sampling
Official title: A National Multicenter Study of Adrenal Venous Sampling for the Subtype Diagnosis of Primary Aldosteronism in China
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hyperaldosteronism
Keywords: Adrenal venous sampling
Hyperaldosteronism
Antecubital approach
Femoral approach
Pathological results
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with confirmed primary aldosteronism aged from 18 to 65 with no limits in sex

Brief summary: This multicenter study intends to combine retrospective analysis and prospective registry to evaluate the success rate and safety of adrenal venous sampling (AVS) via antecubital and femoral approach for patients with primary aldosteronism. The consistency of AVS with pathological results and clinical outcomes, the factors affecting the success of AVS, and the optimal population for AVS will be aslo analyzed in this study.

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. How to improve the success rate of AVS has been a hot topic in the field of primary aldosteronism. This multicenter registry study intends to combine retrospective analysis and prospective registry to evaluate the success rate and safety of AVS via antecubital and femoral approach for patients with primary aldosteronism. The consistency of AVS with pathological results and clinical outcomes, the factors affecting the success of AVS, and the optimal population for AVS will be also analyzed in this study.

Eligibility criteria: Inclusion Criteria:

1. Aged from 18 to 65 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

Primary outcomes:
measure: The success rate of bilateral adrenal venous sampling
timeFrame: At AVS procedure
Secondary outcomes:
measure: The success rate of left adrenal venous sampling
timeFrame: At AVS procedure
measure: The success rate of right adrenal venous sampling
timeFrame: At AVS procedure
measure: Selection of intraoperative catheter
timeFrame: At AVS procedure
measure: Time of the procedure
timeFrame: At AVS procedure
measure: Time of fluoroscopy
timeFrame: At AVS procedure
measure: The contrast agent dosage
timeFrame: At AVS procedure
measure: the incidence of complications
timeFrame: 1 week after AVS procedure
measure: the cost of the procedure
timeFrame: At AVS procedure
measure: pathological results（If the patient underwent adrenalectomy）
timeFrame: 1 week After AVS procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chuiyangliu Hospital affiliated to Tsinghua University
state: Beijing
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
city: Beijing
country: China
facility: Beijing Luhe Hospital, Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: Chongqing General Hospital
state: Chongqing
city: Chongqing
country: China
facility: People's Hospital Affiliated to ChongqingThree Gorges Medical college
state: Chongqing
city: Xiamen
country: China
facility: Cardiovascular Hospital Xiamen University
state: Fujian
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Foshan
country: China
facility: The Forth People's Hosptal of Nanhai District of Foshan City
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences)
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Third People's Hospital，Shenzhen, Guangdong Province 518112, China
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Dapeng New District Kuiyong People's Hospital
state: Guangdong
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Nanning
country: China
facility: Nanning Third People's Hospital
state: Guangxi
city: Kaili
country: China
facility: The Second Affiliated Hospital Of Guizhou Medical University
state: Guizhou
city: Tangshan
country: China
facility: Tangshan hongci Hospital
state: Hebei
city: Ha'erbin
country: China
facility: The First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: Fuwai Central China Cardiovascular Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: Zhengzhou Central Hospital Affiliated to Zhengzhou University
state: Henan
city: Zhengzhou
country: China
facility: Zhengzhou Yihe Hospital
state: Henan
city: Zhoukou
country: China
facility: Zhoukou Central Hospital
state: Henan
city: Xiangyang
country: China
facility: Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science
state: Hubei
city: Yichang
country: China
facility: Yichang Central People's Hospital
state: Hubei
city: Nanchang
country: China
facility: Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital (The First Affiliated Hospital of Nanchang Medical College)
state: Jiangxi
city: Changchun
country: China
facility: Jilin Province FAW General ospital
state: Jilin
city: Dalian
country: China
facility: Frist Aiffiliated Hospital of Dalian Medical University
state: Liaoning
city: Yinchuan
country: China
facility: The First People's Hospital of Yinchuan
state: Ningxia
city: Xining
country: China
facility: Qinghai Province Cardiovascular and Cerebrovascular Disease Specialist Hospital
state: Qinghai
city: Xi'an
country: China
facility: Xi'an People's Hospital
state: Shaanxi
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: Central Hospital Affiliated to Shandong First Medical University
state: Shandong
city: Liaocheng
country: China
facility: People's Hospital of Donga County, Shandong Province
state: Shandong
city: Shanghai
country: China
facility: Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Putuo District Central Hospital
state: Shanghai
city: Taiyuan
country: China
facility: The second hospital of Shanxi medical unversity
state: Shanxi
city: Chengdu
country: China
facility: The Affiliated Hospital of Southwest Jiaotong University, The Third People's Hospital of Chengdu, Chengdu, China
state: Sichuan
city: Chengdu
country: China
facility: The First Affiliated Hospital of Chengdu Medical College
state: Sichuan
city: Chengdu
country: China
facility: Chengdu Fifth People's Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital,
state: Tianjin
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medical University
state: Tianjin
city: Tianjin
country: China
facility: TEDA International Cardiovascular Hospital
state: Tianjin
city: Yili Kazak Autonomous Prefecture
country: China
facility: Yili Kazak Autonomous Prefecture Friendship Hospital
state: Xinjiang
city: Kunming
country: China
facility: Fuwai Yunnan Cardiovascular Hospital
state: Yunnan
city: Hangzhou
country: China
facility: Zhejiang Hospital
state: Zhejiang
Study officials:
affiliation: Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
name: Xiongjing Jiang, MD
role: PRINCIPAL_INVESTIGATOR
References: