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China National Study of Adren...

China National Study of Adrenal Venous Sampling

NCT ID: NCT06192238

Last Updated: 2024-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2026-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hyperaldosteronism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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.

adrenal venous sampling

Intervention Type PROCEDURE

Interventions

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adrenal venous sampling

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Xiongjing Jiang

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiongjing Jiang, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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