China National Study of Adrenal Venous Sampling

Not yet recruiting

• Conditions: Hyperaldosteronism

• 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.

Study Timeline

• Study First Submitted: 2023-12-21
• Status Verified: 2024-01
• Study Start: 2024-01-01
• Study First Submitted QC: 2024-01-04
• Study First Posted: 2024-01-05
• Last Update Submitted: 2024-01-05
• Last Update Posted: 2024-01-09
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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)

Chuiyangliu Hospital affiliated to Tsinghua University; 🇨🇳 Beijing, Beijing, China

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China

Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 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

People's Hospital Affiliated to ChongqingThree Gorges Medical college; 🇨🇳 Chongqing, Chongqing, China

Cardiovascular Hospital Xiamen University; 🇨🇳 Xiamen, Fujian, China

Lanzhou University Second Hospital; 🇨🇳 Lanzhou, Gansu, China

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