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

Primary Aldosteronism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05826080
• Other study ID #: lp2023
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: September 1, 2024

Study information

• Verified date: October 2022
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Ping LI, MD
• Phone: 86-25-83-105302
• Email: li78321[@]yeah.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 59
• Est. completion date: September 1, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 ß-receptor inhibitors, angiotensin converting enzyme inhibitors, angiotensin ? receptor blockers, thiazide diuretics < 2 weeks, aldosterone receptor antagonists < 4 weeks.

6. .Pregnant and lactating women.

Related Conditions & MeSH terms

• Adenoma
• Hyperaldosteronism
• Primary Aldosteronism

Locations

Country	Name	City	State
China	Department of Endocrinology, Drum Tower Hospital affiliated to Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

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