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China National Study of Adrenal Venous Sampling

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06192238
Acronym
CNAVS
Enrollment
1500
Registered
2024-01-05
Start date
2024-01-01
Completion date
2026-12-30
Last updated
2024-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperaldosteronism

Keywords

Adrenal venous sampling, Hyperaldosteronism, Antecubital approach, Femoral approach, Pathological results

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.

Interventions

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.

Sponsors

Chinese Academy of Medical Sciences, Fuwai Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years

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

Design outcomes

Primary

MeasureTime frameDescription
The success rate of bilateral adrenal venous samplingAt AVS procedureSuccessful sampling will be defined by high selectivity index (cortisol in the adrenal vein/cortisol in inferior vena cava \>2 without ACTH simulation)

Secondary

MeasureTime frameDescription
The success rate of right adrenal venous samplingAt AVS procedureSuccessful sampling will be defined by high selectivity index (cortisol in the adrenal vein/cortisol in inferior vena cava \>2 without ACTH simulation)
Selection of intraoperative catheterAt AVS procedureTypes of catheter at the time of Adrenal Venous Sampling via antecubital approach or femoral approach
Time of the procedureAt AVS procedureTime of the procedure
Time of fluoroscopyAt AVS procedureTime of fluoroscopy
The success rate of left adrenal venous samplingAt AVS procedureSuccessful sampling will be defined by high selectivity index (cortisol in the adrenal vein/cortisol in inferior vena cava \>2 without ACTH simulation)
the incidence of complications1 week after AVS procedureComplications related to adrenal vein cannulations (adrenal vein hematoma, inferior vena cava dissection, puncture site hematoma, etc)
the cost of the procedureAt AVS procedurethe cost of the procedure
pathological results(If the patient underwent adrenalectomy)1 week After AVS procedurePathological types of primary aldosteronism(to compare the consistency between adrenal venous sampling results and histopathological results if the patients underwent adrenalectomy.)
The contrast agent dosageAt AVS procedureThe contrast agent dosage

Countries

China

Contacts

Primary ContactXiongjing Jiang, MD
jxj103@hotmail.com86-010-88322387
Backup ContactHui Dong, MD
donghui666@sina.com86-010-88322385

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026