NCT05826080

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

April 24, 2023

Status Verified

October 1, 2022

Enrollment Period

2.1 years

First QC Date

April 11, 2023

Last Update Submit

April 11, 2023

Conditions

Primary AldosteronismAldosterone-Producing AdenomaIdiopathic Hyperaldosteronism

Keywords

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

Outcome Measures

Primary Outcomes (13)

  • Participants' personal information

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

    1 day

  • Physical assessments

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

    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

Study Arms (1)

operative group

Procedure/Surgery:Adrenal Vein Sampling;Adrenalectomy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

primary aldosteronism patients

You may qualify if:

  • Diagnosed as primary aldosteronism.
  • AVS was performed and conservative treatment or adrenalectomy was performed according to the results.
  • Regular follow-up was performed.

You may not qualify if:

  • Adrenal function evaluation suggests that it is complicated with hypercortisolism, subclinical hypercortisolism and pheochromocytoma.
  • Familial aldosteronism.
  • Adrenal mass is considered to be malignant, or pathology suggests adrenocortical carcinoma.
  • Complicated with severe infection, respiratory and circulatory failure, advanced tumor, severe. hepatic and renal insufficiency, neurological, psychiatric and immune deficiency diseases.
  • Drugs: discontinuation of β-receptor inhibitors, angiotensin converting enzyme inhibitors, angiotensin Ⅱ receptor blockers, thiazide diuretics \< 2 weeks, aldosterone receptor antagonists \< 4 weeks.
  • Pregnant and lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology, Drum Tower Hospital affiliated to Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Conditions

HyperaldosteronismAdrenocortical Adenoma

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System DiseasesAdrenal Cortex NeoplasmsAdrenal Gland NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsAdrenal Cortex Diseases

Central Study Contacts

Ping LI, MD

CONTACT

86-25-83-105302li78321@yeah.net

Dalong Zhu, MD

CONTACT

86-25-83-105302zhudalong@nju.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2023

First Posted

April 24, 2023

Study Start

September 1, 2021

Primary Completion

October 1, 2023

Study Completion

September 1, 2024

Last Updated

April 24, 2023

Record last verified: 2022-10

Locations

CN(1)