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Effect of Adrenocorticotropic Hormone Stimulation During Adrenal Vein Sampling in Primary Aldosteronism

The Cross-sectional Study and Longitudinal Study of the the Value of Adrenocorticotrophic Hormonestimulation in Adrenal Vein Sampling

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05826080
Enrollment
59
Registered
2023-04-24
Start date
2021-09-01
Completion date
2024-09-01
Last updated
2023-04-24

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

Conditions

Aldosterone-Producing Adenoma, Idiopathic Hyperaldosteronism, Primary Aldosteronism

Keywords

Primary aldosteronism; Adrenal vein sampling; Adrenocorticotrophic hormone; Selectivity index; Lateralization index; prognosis

Brief summary

The purpose of our research is to evaluate the value of ACTH stimulation in AVS especially in lateralization is still controversial.

Detailed description

Primary aldosteronism (PA) is thought to be the most common secondary endocrine form of hypertension. A recent published study revealed that the prevalence of PA in patients with newly diagnosed hypertension in China was at least 4%. Compared with patients with essential hypertension with similar blood pressure, patients with PA have significantly higher atrial fibrillation, myocardial infarction, heart failure, stroke, deterioration of renal function and all-cause mortality. Therefore, early and systematic implementation of effective surgical or medical treatment is essential to prevent or reverse the excess vascular events and mortality of these patients. Adrenal venous sampling (AVS) is key for reliable subtype identification recommended by different guidelines and consensus statements. However, AVS is a complex, technically challenging and expensive procedure, requiring proficient and dedicated interventional radiologists. More importantly, the standardised procedure and method of AVS have not been unified10. Adrenocorticotropic hormone (ACTH) infusion is employed by many centers to maximize the gradient in cortisol from the adrenal vein to the inferior vena cava, and to maximize aldosterone secretion from an aldosterone-producing adenomas (APA) and thus avoid the risk of sampling during a relatively quiescent phase of aldosterone secretion. There is no debate that ACTH stimulation increases the selectivity index (SI) and, therefore, greatly increases the likelihood of successful AVS. However, the effect of ACTH stimulation on the lateralization index (LI) is controversial, with several studies reporting a reduction in the proportion of lateralized AVS results and, therefore, of surgically treatable patients. Hitherto, most of the studies on the value of using ACTH stimulation in AVS are retrospective studies with a small sample size, or multi-center studies with ununified methods of ACTH stimulation and evaluation standards of results. Therefore, there are obvious heterogeneity in the results and the value of evidence is limited. In this prospective study, we analyzed the SI and LI in simultaneous bilateral AVS at baseline and after ACTH stimulation in our center, and further estimated the prognosis of patients underwent adrenalectomy with different cut-off points of LI after ACTH stimulation. Present study will provide novel evidence for the value of ACTH stimulation in AVS and improve AVS procedure.

Interventions

None listed

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. Diagnosed as primary aldosteronism. 2. AVS was performed and conservative treatment or adrenalectomy was performed according to the results. 3. Regular follow-up was performed.

Exclusion criteria

1. Adrenal function evaluation suggests that it is complicated with hypercortisolism, subclinical hypercortisolism and pheochromocytoma. 2. Familial aldosteronism. 3. .Adrenal mass is considered to be malignant, or pathology suggests adrenocortical carcinoma. 4. .Complicated with severe infection, respiratory and circulatory failure, advanced tumor, severe. hepatic and renal insufficiency, neurological, psychiatric and immune deficiency diseases. 5. .Drugs: discontinuation of β-receptor inhibitors, angiotensin converting enzyme inhibitors, angiotensin Ⅱ receptor blockers, thiazide diuretics \< 2 weeks, aldosterone receptor antagonists \< 4 weeks. 6. .Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frameDescription
24-hour urine electrolytes1 day24-hour urine potassium
Participants' personal information1 daySelf-reported information (the cause of discovering adrenal adenoma)
Physical assessments1 dayBMI(body mess index) in kg/m\^2
Screening test of primary aldosteronism(Supine standing test)1 dayplasma aldosterone concentration in the supine position and standing position
Confirmatory test of primary aldosteronism(Captopril test)1 dayplasma aldosterone concentration at 8:00 am and 10:00 am
circadian cortisol rhythm1 dayadrenocorticotropic hormone at 8:00am、16:00pm and 0:00am
Cortisol metabolism1 day24-hours urine free cortisol
1 mg (overnight) dexamethasone suppression test1 dayPlasma cortisol concentration at 8:00am
Other indicators of adrenal function1 day24h urinary,plasma catecholamines and their metabolites
Imaging of adrenal adenoma1 dayunenhanced and contrast-enhanced CT of adrenal

Countries

China

Contacts

Primary ContactPing LI, MD
li78321@yeah.net86-25-83-105302
Backup ContactDalong Zhu, MD
zhudalong@nju.edu.cn86-25-83-105302

Outcome results

None listed

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