An observational study in Primary Aldosteronism, Aldosterone-Producing Adenoma and Idiopathic Hyperaldosteronism, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-04-24.
Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Observational
The purpose of our research is to evaluate the value of ACTH stimulation in AVS especially in lateralization is still controversial.
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.
657 studies on the registry are indexed under Adenoma; 98 are open to participants now.
This study's planned enrollment of 59 is below the median of 300 across 226 observational studies indexed under Adenoma.
Browse Adenoma studies →The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 242 studies on the registry; 144 are open to participants now.
Counted across the registry records on this site, refreshed daily.
primary aldosteronism patients
Exclusion Criteria:
Procedure/Surgery:Adrenal Vein Sampling;Adrenalectomy
Participants' personal information
Self-reported information (the cause of discovering adrenal adenoma)
Time frame: 1 day
Physical assessments
BMI(body mess index) in kg/m\^2
Time frame: 1 day
Screening test of primary aldosteronism(Supine standing test)
plasma aldosterone concentration in the supine position and standing position
Time frame: 1 day
Screening test of primary aldosteronism(Supine standing test)
plasma renin concentration in the supine position and standing position
Time frame: 1 day
Confirmatory test of primary aldosteronism(Captopril test)
plasma aldosterone concentration at 8:00 am and 10:00 am
Time frame: 1 day
Confirmatory test of primary aldosteronism(Captopril test)
plasma renin concentration at 8:00 am and 10:00 am
Time frame: 1 day
circadian cortisol rhythm
adrenocorticotropic hormone at 8:00am、16:00pm and 0:00am
Time frame: 1 day
circadian cortisol rhythm
Plasma cortisol concentration at 8:00am、16:00pm and 0:00am
Time frame: 1 day
Cortisol metabolism
24-hours urine free cortisol
Time frame: 1 day
1 mg (overnight) dexamethasone suppression test
Plasma cortisol concentration at 8:00am
Time frame: 1 day
Other indicators of adrenal function
24h urinary,plasma catecholamines and their metabolites
Time frame: 1 day
24-hour urine electrolytes
24-hour urine potassium
Time frame: 1 day
Imaging of adrenal adenoma
unenhanced and contrast-enhanced CT of adrenal
Time frame: 1 day
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School