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Trial Title:
Effect of Adrenocorticotropic Hormone Stimulation During Adrenal Vein Sampling in Primary Aldosteronism
NCT ID:
NCT05826080
Condition:
Primary Aldosteronism
Aldosterone-Producing Adenoma
Idiopathic Hyperaldosteronism
Conditions: Official terms:
Adenoma
Hyperaldosteronism
Conditions: Keywords:
Primary aldosteronism; Adrenal vein sampling; Adrenocorticotrophic hormone; Selectivity index; Lateralization index; prognosis
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
primary aldosteronism patients
Sampling method:
Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Endocrinology, Drum Tower Hospital affiliated to Nanjing University Medical School
Address:
City:
Nanjing
Zip:
210008
Country:
China
Status:
Recruiting
Contact:
Last name:
Dalong Zhu, MD,PhD
Phone:
86-25-83-105302
Email:
zhudalong@nju.edu.cn
Contact backup:
Last name:
Ping Li, MD,PhD
Phone:
86-25-83-105302
Email:
li78321@yeah.net
Investigator:
Last name:
Dalong Zhu, MD,PhD
Email:
Principal Investigator
Investigator:
Last name:
Ping Li, MD,PhD
Email:
Sub-Investigator
Start date:
September 1, 2021
Completion date:
September 1, 2024
Lead sponsor:
Agency:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Agency class:
Other
Source:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05826080
