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Status unknownNCT05826080Updated Apr 24, 2023

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

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 sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
59
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Primary Aldosteronism
  • Aldosterone-Producing Adenoma
  • Idiopathic Hyperaldosteronism

Keywords

  • Primary aldosteronism; Adrenal vein sampling; Adrenocorticotrophic hormone; Selectivity index; Lateralization index; prognosis
03

In context

Adenoma

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

primary aldosteronism patients

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
59 participants (estimated)
Patient registry
No

Groups and cohorts

  • operative group

    Procedure/Surgery:Adrenal Vein Sampling;Adrenalectomy

06

What researchers measure

Primary outcomes

  1. Participants' personal information

    Self-reported information (the cause of discovering adrenal adenoma)

    Time frame: 1 day

  2. Physical assessments

    BMI(body mess index) in kg/m\^2

    Time frame: 1 day

  3. Screening test of primary aldosteronism(Supine standing test)

    plasma aldosterone concentration in the supine position and standing position

    Time frame: 1 day

  4. Screening test of primary aldosteronism(Supine standing test)

    plasma renin concentration in the supine position and standing position

    Time frame: 1 day

  5. Confirmatory test of primary aldosteronism(Captopril test)

    plasma aldosterone concentration at 8:00 am and 10:00 am

    Time frame: 1 day

  6. Confirmatory test of primary aldosteronism(Captopril test)

    plasma renin concentration at 8:00 am and 10:00 am

    Time frame: 1 day

  7. circadian cortisol rhythm

    adrenocorticotropic hormone at 8:00am、16:00pm and 0:00am

    Time frame: 1 day

  8. circadian cortisol rhythm

    Plasma cortisol concentration at 8:00am、16:00pm and 0:00am

    Time frame: 1 day

  9. Cortisol metabolism

    24-hours urine free cortisol

    Time frame: 1 day

  10. 1 mg (overnight) dexamethasone suppression test

    Plasma cortisol concentration at 8:00am

    Time frame: 1 day

  11. Other indicators of adrenal function

    24h urinary,plasma catecholamines and their metabolites

    Time frame: 1 day

  12. 24-hour urine electrolytes

    24-hour urine potassium

    Time frame: 1 day

  13. Imaging of adrenal adenoma

    unenhanced and contrast-enhanced CT of adrenal

    Time frame: 1 day

07

Study locations

1 of 1 sites recruiting
  • Department of Endocrinology, Drum Tower Hospital affiliated to Nanjing University Medical School
    Nanjing, Jiangsu 210008, China
    • Dalong Zhu, MD,PhD · Contact · zhudalong@nju.edu.cn · 86-25-83-105302
    • Ping Li, MD,PhD · Contact · li78321@yeah.net · 86-25-83-105302
    • Dalong Zhu, MD,PhD · Principal investigator
    • Ping Li, MD,PhD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05826080
Lead sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Responsible party
Sponsor
First posted
Apr 24, 2023
Start date
Sep 1, 2021
Primary completion
Oct 1, 2023 (estimated)
Completion
Sep 1, 2024 (estimated)
Last update
Apr 24, 2023

Study contacts

Ping LI, MD
Contact
li78321@yeah.net
86-25-83-105302
Dalong Zhu, MD
Contact
zhudalong@nju.edu.cn
86-25-83-105302

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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