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

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

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

Study Overview

• Status: Recruiting
• Conditions: Primary Aldosteronism; Aldosterone-Producing Adenoma; Idiopathic Hyperaldosteronism

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.

• Study Type: Observational
• Enrollment (Anticipated): 59

Contacts and Locations

• Study Contact: Name: Ping LI, MD; Phone Number: 86-25-83-105302; Email: li78321@yeah.net
• Study Contact Backup: Name: Dalong Zhu, MD; Phone Number: 86-25-83-105302; Email: zhudalong@nju.edu.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • Department of Endocrinology, Drum Tower Hospital affiliated to Nanjing University Medical School
      • Contact: Dalong Zhu, MD,PhD; Phone Number: 86-25-83-105302; Email: zhudalong@nju.edu.cn
      • Contact: Ping Li, MD,PhD; Phone Number: 86-25-83-105302; Email: li78321@yeah.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

primary aldosteronism patients

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
operative group; Procedure/Surgery:Adrenal Vein Sampling;Adrenalectomy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: April 11, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Primary aldosteronism; Adrenal vein sampling; Adrenocorticotrophic hormone; Selectivity index; Lateralization index; prognosis
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Adenoma; Hyperaldosteronism
• Other Study ID Numbers: lp2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No