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NCT Number: NCT07252284

CHina Adrenal Venous saMPling InvestigatiON

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.

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Key information

Conditions

Hyperaldosteronism Adrenal Gland Diseases Adrenal Venous Sampling Adrenalectomy Adrenocortical Hyperfunction Endocrine System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The first affiliated hospital of USTC, Hefei, Anhui, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

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. Major adverse cardiovascular events (MACE) at 1-year follow-up

    Time frame: 1 year after AVS procedure

    Incidence of major adverse cardiovascular events (MACE) at 1-year follow-up, including stroke, heart failure, severe arrhythmias, renal failure, myocardial infarction, and death.

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. 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)

  4. 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

  5. Time of the procedure

    Time frame: At AVS procedure

    Time of the procedure

  6. Time of fluoroscopy

    Time frame: At AVS procedure

    Time of fluoroscopy

  7. The contrast agent dosage

    Time frame: At AVS procedure

    The contrast agent dosage

  8. 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)

  9. the cost of the procedure

    Time frame: At AVS procedure

    the cost of the procedure

  10. 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

    The difference in average systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring (ABPM) between baseline and each follow-up time point.

  11. 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

    The difference in average diastolic blood pressure measured by 24-hour ambulatory blood pressure monitoring (ABPM) bewteen baseline and each follow-up time point.

  12. 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

    The difference in systolic blood pressure measured during clinic visits (office blood pressure) between baseline and each follow-up time point

  13. Change in office diastolic blood pressure

    Time frame: At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment

    The difference in diastolic blood pressure measured during clinic visits (office blood pressure) between baseline and each follow-up time point

  14. Change in antihypertensive medication burden

    Time frame: At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment

    The change in the number and/or dosage of antihypertensive medications taken by patients between baseline and each follow-up time point

  15. Change in urinary albumin-to-creatinine ratio (UACR)

    Time frame: At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment

    The difference in urinary albumin-to-creatinine ratio measured at baseline and at each follow-up time point

  16. Change in left ventricular mass index (LVMI)

    Time frame: At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment

    The change in left ventricular mass index, as assessed by echocardiography, from baseline to each follow-up time point.

  17. Change in pulse wave velocity (PWV) from baseline

    Time frame: At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment

    The change in pulse wave velocity measured between baseline and each follow-up time point。

  18. Clinical Outcome According to Primary Aldosteronism Surgical Outcome (PASO) Criteria

    Time frame: At 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after surgery

    Clinical outcomes will be assessed at each follow-up visit afteradrenal surgery according to the PASO consensus criteria. Outcomes will be categorized as:

    (1)Complete clinical success: normal blood pressure without the need for any antihypertensive medication. (2)Partial clinical success: improvement in blood pressure and/or a reduction in the number or dosage of antihypertensive medications. (3)Absent clinical success: no improvement in blood pressure or antihypertensive medication burden.

  19. Biochemical Outcome According to Primary Aldosteronism Surgical Outcome (PASO) Criteria

    Time frame: At 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after surgery

    Biochemical outcomes will be assessed at each follow-up visit after adrenal surgery according to the PASO consensus classification. Outcomes will be categorized as:(1)Complete biochemical success: normal serum potassium levels and a normalized aldosterone-to-renin ratio (ARR) without the need for potassium supplementation.(2)Partial biochemical success: improvement in biochemical parameters without full normalization.(3)Absent biochemical success: no improvement in biochemical markers compared to baseline.

  20. Major adverse cardiovascular events (MACE)

    Time frame: At 6 and 18 months; and 2, 3, 4, 5, and 10 years after AVS procedure

    Incidence of major adverse cardiovascular events (MACE), including stroke, heart failure, severe arrhythmias, renal failure, myocardial infarction, and death.

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

China Adrenal Venous Sampling Investigation: A National Multicenter Study

Acronym: CHAMPION

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Nov 26, 2025
Registry last updated
Nov 26, 2025

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.

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