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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05826080
Other study ID # lp2023
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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