China National Study of Adrenal Venous Sampling

Hyperaldosteronism Clinical Trial

— CNAVS  

Official title:

A National Multicenter Study of Adrenal Venous Sampling for the Subtype Diagnosis of Primary Aldosteronism in China

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06192238
• Other study ID #: 20231120
• Status: Not yet recruiting
• Start date: January 1, 2024
• Est. completion date: December 30, 2026

Study information

• Verified date: January 2024
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Xiongjing Jiang, MD
• Phone: 86-010-88322387
• Email: jxj103[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: December 30, 2026
• Est. primary completion date: December 30, 2026
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperaldosteronism

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	Beijing Luhe Hospital, Capital Medical University	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Chuiyangliu Hospital affiliated to Tsinghua University	Beijing	Beijing
China	Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Jilin Province FAW General ospital	Changchun	Jilin
China	Chengdu Fifth People's Hospital	Chengdu	Sichuan
China	The Affiliated Hospital of Southwest Jiaotong University, The Third People's Hospital of Chengdu, Chengdu, China	Chengdu	Sichuan
China	The First Affiliated Hospital of Chengdu Medical College	Chengdu	Sichuan
China	Chongqing General Hospital	Chongqing	Chongqing
China	People's Hospital Affiliated to ChongqingThree Gorges Medical college	Chongqing	Chongqing
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Frist Aiffiliated Hospital of Dalian Medical University	Dalian	Liaoning
China	The Forth People's Hosptal of Nanhai District of Foshan City	Foshan	Guangdong
China	Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences)	Guangzhou	Guangdong
China	The First Affiliated Hospital of Harbin Medical University	Ha'erbin	Heilongjiang
China	Zhejiang Hospital	Hangzhou	Zhejiang
China	Central Hospital Affiliated to Shandong First Medical University	Jinan	Shandong
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	The Second Affiliated Hospital Of Guizhou Medical University	Kaili	Guizhou
China	Fuwai Yunnan Cardiovascular Hospital	Kunming	Yunnan
China	Lanzhou University Second Hospital	Lanzhou	Gansu
China	People's Hospital of Donga County, Shandong Province	Liaocheng	Shandong
China	Jiangxi Provincial People's Hospital (The First Affiliated Hospital of Nanchang Medical College)	Nanchang	Jiangxi
China	Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Nanning Third People's Hospital	Nanning	Guangxi
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Shanghai Putuo District Central Hospital	Shanghai	Shanghai
China	Shenzhen Dapeng New District Kuiyong People's Hospital	Shenzhen	Guangdong
China	Shenzhen Third People's Hospital,Shenzhen, Guangdong Province 518112, China	Shenzhen	Guangdong
China	The second hospital of Shanxi medical unversity	Taiyuan	Shanxi
China	Tangshan hongci Hospital	Tangshan	Hebei
China	TEDA International Cardiovascular Hospital	Tianjin	Tianjin
China	The Second Hospital of Tianjin Medical University	Tianjin	Tianjin
China	Tianjin Medical University General Hospital,	Tianjin	Tianjin
China	Xi'an People's Hospital	Xi'an	Shaanxi
China	Cardiovascular Hospital Xiamen University	Xiamen	Fujian
China	Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science	Xiangyang	Hubei
China	Qinghai Province Cardiovascular and Cerebrovascular Disease Specialist Hospital	Xining	Qinghai
China	Yichang Central People's Hospital	Yichang	Hubei
China	Yili Kazak Autonomous Prefecture Friendship Hospital	Yili Kazak Autonomous Prefecture	Xinjiang
China	The First People's Hospital of Yinchuan	Yinchuan	Ningxia
China	Fuwai Central China Cardiovascular Hospital	Zhengzhou	Henan
China	Henan Provincial People's Hospital	Zhengzhou	Henan
China	Zhengzhou Central Hospital Affiliated to Zhengzhou University	Zhengzhou	Henan
China	Zhengzhou Yihe Hospital	Zhengzhou	Henan
China	Zhoukou Central Hospital	Zhoukou	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 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	Types of catheter at the time of Adrenal Venous Sampling via antecubital approach or femoral approach	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
Secondary	pathological results(If the patient underwent adrenalectomy)	Pathological types of primary aldosteronism(to compare the consistency between adrenal venous sampling results and histopathological results if the patients underwent adrenalectomy.)	1 week After AVS procedure