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Not yet recruiting NCT06192238

China National Study of Adrenal Venous Sampling

— Observational Hyperaldosteronism

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. Basic parameters: 18 years — 65 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

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

Overview

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.

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

  • The success rate of bilateral adrenal venous sampling [Time frame: At AVS procedure]
Secondary outcome measures (9)
  • 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]
  • 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]
  • pathological results（If the patient underwent adrenalectomy） [Time frame: 1 week After AVS procedure]

Eligibility criteria

Inclusion criteria

  • 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；

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.

Study design

Observational model
Cohort

Study locations

China · 48 centers
  • 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
  • Beijing Luhe Hospital, Capital Medical University — Beijing
  • The First Affiliated Hospital of Chongqing Medical University — Chongqing
  • Chongqing General Hospital — Chongqing
  • People's Hospital Affiliated to ChongqingThree Gorges Medical college — Chongqing
  • … and 40 more centers

Identifiers

NCT: NCT06192238 · 20231120

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗