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

Recruiting

• Conditions: Primary Aldosteronism; Idiopathic Hyperaldosteronism; Aldosterone-Producing Adenoma

• Registration Number: NCT05826080
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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.

Study Timeline

• Study Start: 2021-09-01
• Status Verified: 2022-10
• Study First Submitted: 2023-04-11
• Study First Submitted QC: 2023-04-11
• Last Update Submitted: 2023-04-11
• Study First Posted: 2023-04-24
• Last Update Posted: 2023-04-24
• Primary Completion: 2023-10-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 59

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cortisol metabolism	1 day	24-hours urine free cortisol
Physical assessments	1 day	BMI(body mess index) in kg/m\^2
Participants' personal information	1 day	Self-reported information (the cause of discovering adrenal adenoma）
Screening test of primary aldosteronism（Supine standing test）	1 day	plasma renin concentration in the supine position and standing position
Confirmatory test of primary aldosteronism（Captopril test）	1 day	plasma renin concentration at 8：00 am and 10：00 am
circadian cortisol rhythm	1 day	Plasma cortisol concentration at 8：00am、16：00pm and 0：00am
1 mg (overnight) dexamethasone suppression test	1 day	Plasma cortisol concentration at 8：00am
24-hour urine electrolytes	1 day	24-hour urine potassium
Other indicators of adrenal function	1 day	24h urinary，plasma catecholamines and their metabolites
Imaging of adrenal adenoma	1 day	unenhanced and contrast-enhanced CT of adrenal

Trial Locations

Locations (1)

Department of Endocrinology, Drum Tower Hospital affiliated to Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China