Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06192238

China National Study of Adrenal Venous Sampling

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Luhe Hospital, Capital Medical University, Beijing, Beijing Municipality, China

Loading trial locations.

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

adrenal venous sampling

Procedure

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 outcomes

  1. The success rate of bilateral adrenal venous sampling

    Time frame: 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 outcomes

  1. The success rate of left adrenal venous sampling

    Time frame: 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)

  2. The success rate of right adrenal venous sampling

    Time frame: 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)

  3. Selection of intraoperative catheter

    Time frame: At AVS procedure

    Types of catheter at the time of Adrenal Venous Sampling via antecubital approach or femoral approach

  4. Time of the procedure

    Time frame: At AVS procedure

    Time of the procedure

  5. Time of fluoroscopy

    Time frame: At AVS procedure

    Time of fluoroscopy

  6. The contrast agent dosage

    Time frame: At AVS procedure

    The contrast agent dosage

  7. the incidence of complications

    Time frame: 1 week after AVS procedure

    Complications related to adrenal vein cannulations (adrenal vein hematoma, inferior vena cava dissection, puncture site hematoma, etc)

  8. the cost of the procedure

    Time frame: At AVS procedure

    the cost of the procedure

  9. pathological results(If the patient underwent adrenalectomy)

    Time frame: 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.)

Study contacts

Contact information is provided by the study sponsor or research team.

Hui Dong, MD

CONTACT

[email protected]

86-010-88322385

Xiongjing Jiang, MD

CONTACT

[email protected]

86-010-88322387

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Registry information

Official study title

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

Acronym: CNAVS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 5, 2024
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.