China National Study of Adrenal Venous Sampling
- Conditions
- Hyperaldosteronism
- Interventions
- Procedure: adrenal venous sampling
- Registration Number
- NCT06192238
- Lead Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1500
- Aged from 18 to 65 with no limits in sex;
- Patients with confirmed primary aldosteronism;
- Patients or their legal representatives sign written informed consent approved by the ethics committee；
- Severe comorbidity, including stroke, myocardial infarction, heart failure, severe valvular heart disease, liver cirrhosis, and metastatic tumor within the previous 3 months；
- An estimated glomerular filtration rate <45 ml/min/1.73 m2, or serum creatinine >176 μmol/L；
- Patients who refuse adrenalectomy;
- Suspected of having an adrenocortical carcinoma;
- Allergy to contrast agent;
- Pregnant, nursing, or planning to become pregnant
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Adrenal Venous Sampling adrenal venous sampling Patients with Primary Aldosteronism (PA) undergoing Adrenal Venous Sampling via antecubital approach or femoral approach to discriminate PA forms with unilateral from bilateral excess aldosterone production.
- 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 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)
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 the procedure At AVS procedure Time of the procedure
The contrast agent dosage At AVS procedure The contrast agent dosage
pathological results（If the patient underwent adrenalectomy） 1 week After AVS procedure Pathological types of primary aldosteronism（to compare the consistency between adrenal venous sampling results and histopathological results if the patients underwent adrenalectomy.）
the cost of the procedure At AVS procedure the cost of the procedure
Time of fluoroscopy At AVS procedure Time of fluoroscopy
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)
Selection of intraoperative catheter At AVS procedure Types of catheter at the time of Adrenal Venous Sampling via antecubital approach or femoral approach
Trial Locations
- Locations (48)
People's Hospital Affiliated to ChongqingThree Gorges Medical college
🇨🇳Chongqing, Chongqing, 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 Guangxi Medical University
🇨🇳Nanning, Guangxi, China
The Second Affiliated Hospital Of Guizhou Medical University
🇨🇳Kaili, Guizhou, China
Yichang Central People's Hospital
🇨🇳Yichang, Hubei, China
Jiangxi Provincial People's Hospital (The First Affiliated Hospital of Nanchang Medical College)
🇨🇳Nanchang, Jiangxi, China
Chengdu Fifth People's Hospital
🇨🇳Chengdu, Sichuan, China
Tianjin Medical University General Hospital,
🇨🇳Tianjin, Tianjin, China
Yili Kazak Autonomous Prefecture Friendship Hospital
🇨🇳Yili Kazak Autonomous Prefecture, Xinjiang, China
Fuwai Yunnan Cardiovascular Hospital
🇨🇳Kunming, Yunnan, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, China
Chuiyangliu Hospital affiliated to Tsinghua University
🇨🇳Beijing, Beijing, China
Beijing Luhe Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Chongqing General Hospital
🇨🇳Chongqing, Chongqing, China
Cardiovascular Hospital Xiamen University
🇨🇳Xiamen, Fujian, China
Lanzhou University Second Hospital
🇨🇳Lanzhou, Gansu, China
The Forth People's Hosptal of Nanhai District of Foshan City
🇨🇳Foshan, Guangdong, China
Shenzhen Third People's Hospital，Shenzhen, Guangdong Province 518112, China
🇨🇳Shenzhen, Guangdong, China
Shenzhen Dapeng New District Kuiyong People's Hospital
🇨🇳Shenzhen, Guangdong, China
Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences)
🇨🇳Guangzhou, Guangdong, China
Nanning Third People's Hospital
🇨🇳Nanning, Guangxi, China
The First Affiliated Hospital of Harbin Medical University
🇨🇳Ha'erbin, Heilongjiang, China
Tangshan hongci Hospital
🇨🇳Tangshan, Hebei, China
Fuwai Central China Cardiovascular Hospital
🇨🇳Zhengzhou, Henan, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
Zhengzhou Yihe Hospital
🇨🇳Zhengzhou, Henan, China
Zhengzhou Central Hospital Affiliated to Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Jilin Province FAW General ospital
🇨🇳Changchun, Jilin, China
Zhoukou Central Hospital
🇨🇳Zhoukou, Henan, China
Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science
🇨🇳Xiangyang, Hubei, China
Frist Aiffiliated Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The First People's Hospital of Yinchuan
🇨🇳Yinchuan, Ningxia, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Qinghai Province Cardiovascular and Cerebrovascular Disease Specialist Hospital
🇨🇳Xining, Qinghai, China
Xi'an People's Hospital
🇨🇳Xi'an, Shaanxi, China
Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
People's Hospital of Donga County, Shandong Province
🇨🇳Liaocheng, Shandong, China
Central Hospital Affiliated to Shandong First Medical University
🇨🇳Jinan, Shandong, China
Shanghai Putuo District Central Hospital
🇨🇳Shanghai, Shanghai, China
The Affiliated Hospital of Southwest Jiaotong University, The Third People's Hospital of Chengdu, Chengdu, China
🇨🇳Chengdu, Sichuan, China
The second hospital of Shanxi medical unversity
🇨🇳Taiyuan, Shanxi, China
The First Affiliated Hospital of Chengdu Medical College
🇨🇳Chengdu, Sichuan, China
The Second Hospital of Tianjin Medical University
🇨🇳Tianjin, Tianjin, China
TEDA International Cardiovascular Hospital
🇨🇳Tianjin, Tianjin, China
Zhejiang Hospital
🇨🇳Hangzhou, Zhejiang, China