CHina Adrenal Venous saMPling InvestigatiON
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: adrenal venous sampling.
- Who it may be relevant to
- Registry conditions: Hyperaldosteronism, Adrenal Venous Sampling, Adrenalectomy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
China Adrenal Venous Sampling Investigation: A National Multicenter Study
Overview
Primary aldosteronism (PA) is a major cause of secondary hypertension, yet its optimal diagnosis and management remain challenging. This study comprehensively evaluates adrenal venous sampling (AVS), addressing key clinical, technical, and methodological issues, and aims to clarify the relationship between AVS-guided management and long-term clinical and biochemical outcomes to optimize patient care and prognosis.
Detailed description
Primary aldosteronism (PA) is one of the most common causes of secondary hypertension, yet its optimal diagnostic and therapeutic strategies remain challenging. Adrenal venous sampling (AVS) is regarded as the gold standard for subtype differentiation; however, important clinical, technical, and methodological issues have not been systematically addressed. This study is designed to comprehensively evaluate AVS and its clinical implications, aiming to elucidate the relationship between AVS-guided diagnosis and management of PA and long-term clinical and biochemical outcomes, while refining AVS protocols, standardizing clinical practice, optimizing therapeutic decision-making, and ultimately improving patient management and prognosis.
Interventions
- 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.
Primary outcome measures
- Major adverse cardiovascular events (MACE) at 1-year follow-up [Time frame: 1 year after AVS procedure]
Secondary outcome measures (12)
- The success rate of left adrenal venous sampling [Time frame: At AVS procedure]
- The success rate of right adrenal venous sampling [Time frame: At AVS procedure]
- The success rate of bilateral adrenal venous sampling [Time frame: At AVS procedure]
- Selection of intraoperative catheter [Time frame: At AVS procedure]
- Time of the procedure [Time frame: At AVS procedure]
- Time of fluoroscopy [Time frame: At AVS procedure]
- The contrast agent dosage [Time frame: At AVS procedure]
- the incidence of complications [Time frame: 1 week after AVS procedure]
- the cost of the procedure [Time frame: At AVS procedure]
- Change in 24-hour ambulatory systolic blood pressure [Time frame: At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment]
- Change in 24-hour ambulatory diastolic blood pressure [Time frame: At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment]
- Change in office systolic blood pressure [Time frame: At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment]
Eligibility criteria
Inclusion criteria
- Patients with confirmed primary aldosteronism;
- Patients undergoing adrenal venous sampling for subtype classification of primary aldosteronism.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 76 centers
- The first affiliated hospital of USTC — Hefei
- Chuiyangliu Hospital affiliated to Tsinghua University — Beijing
- China-Japan Friendship Hospital — Beijing
- Peking University First Hospital — Beijing
- Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sci — Beijing
- Peking University People's Hospital — Beijing
- Beijing Luhe Hospital, Capital Medical University — Beijing
- Chongqing University Central Hospital — Chongqing
- … and 68 more centers
Identifiers
NCT: NCT07252284 · 2024-2484