Primary AldosteronismNCT05826080
Effect of Adrenocorticotropic Hormone Stimulation During Adrenal Vein Sampling in Primary Aldosteronism
An observational study of Primary Aldosteronism and Aldosterone-Producing Adenoma, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
The purpose of our research is to evaluate the value of ACTH stimulation in AVS especially in lateralization is still controversial. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Aldosteronism, Aldosterone-Producing Adenoma, Idiopathic Hyperaldosteronism
- How many people
- 59 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary aldosteronism patients
Who may be able to join
- Diagnosed as primary aldosteronism.
- AVS was performed and conservative treatment or adrenalectomy was performed according to the results.
- Regular follow-up was performed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Endocrinology, Drum Tower Hospital affiliated to Nanjing University Medical School
Nanjing, Jiangsu, 210008
Dalong Zhu, MD,PhD, 86-25-83-105302, zhudalong@nju.edu.cn
Ping Li, MD,PhD, 86-25-83-105302, li78321@yeah.net
About this study
Official title: 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.
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.
- Keywords
- Primary aldosteronism; Adrenal vein sampling; Adrenocorticotrophic hormone; Selectivity index; Lateralization index; prognosis
- Medical subject headings
- Hyperaldosteronism, Adrenocortical Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| operative group | Procedure/Surgery:Adrenal Vein Sampling;Adrenalectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants' personal information
Self-reported information (the cause of discovering adrenal adenoma）
Measured: 1 day
Physical assessments
BMI(body mess index) in kg/m^2
Measured: 1 day
Screening test of primary aldosteronism（Supine standing test）
plasma aldosterone concentration in the supine position and standing position
Measured: 1 day
Screening test of primary aldosteronism（Supine standing test）
plasma renin concentration in the supine position and standing position
Measured: 1 day
Confirmatory test of primary aldosteronism（Captopril test）
plasma aldosterone concentration at 8：00 am and 10：00 am
Measured: 1 day
Confirmatory test of primary aldosteronism（Captopril test）
plasma renin concentration at 8：00 am and 10：00 am
Measured: 1 day
circadian cortisol rhythm
adrenocorticotropic hormone at 8：00am、16：00pm and 0：00am
Measured: 1 day
circadian cortisol rhythm
Plasma cortisol concentration at 8：00am、16：00pm and 0：00am
Measured: 1 day
Cortisol metabolism
24-hours urine free cortisol
Measured: 1 day
1 mg (overnight) dexamethasone suppression test
Plasma cortisol concentration at 8：00am
Measured: 1 day
Other indicators of adrenal function
24h urinary，plasma catecholamines and their metabolites
Measured: 1 day
24-hour urine electrolytes
24-hour urine potassium
Measured: 1 day
Imaging of adrenal adenoma
unenhanced and contrast-enhanced CT of adrenal
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start1 Sep 2021
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826080
- Sponsor's protocol ID
- lp2023
- Status last verified
- Oct 2022
- First submitted
- 11 Apr 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cross-sectional Study and Longitudinal Study of the the Value of Adrenocorticotrophic Hormonestimulation in Adrenal Vein Sampling
- ClinicalTrials.gov ID
- NCT05826080
- Acronym / sponsor ID
- lp2023
- Keywords
- Primary aldosteronism; Adrenal vein sampling; Adrenocorticotrophic hormone; Selectivity index; Lateralization index; prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| operative group | – | –Procedure/Surgery:Adrenal Vein Sampling;Adrenalectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary aldosteronism patients
Key inclusion criteria (3 listed)
- Diagnosed as primary aldosteronism.
- AVS was performed and conservative treatment or adrenalectomy was performed according to the results.
- Regular follow-up was performed.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Participants' personal information
Time frame: 1 day
Self-reported information (the cause of discovering adrenal adenoma）
Physical assessments
Time frame: 1 day
BMI(body mess index) in kg/m^2
Screening test of primary aldosteronism（Supine standing test）
Time frame: 1 day
plasma aldosterone concentration in the supine position and standing position
Screening test of primary aldosteronism（Supine standing test）
Time frame: 1 day
plasma renin concentration in the supine position and standing position
Confirmatory test of primary aldosteronism（Captopril test）
Time frame: 1 day
plasma aldosterone concentration at 8：00 am and 10：00 am
Confirmatory test of primary aldosteronism（Captopril test）
Time frame: 1 day
plasma renin concentration at 8：00 am and 10：00 am
circadian cortisol rhythm
Time frame: 1 day
adrenocorticotropic hormone at 8：00am、16：00pm and 0：00am
circadian cortisol rhythm
Time frame: 1 day
Plasma cortisol concentration at 8：00am、16：00pm and 0：00am
Cortisol metabolism
Time frame: 1 day
24-hours urine free cortisol
1 mg (overnight) dexamethasone suppression test
Time frame: 1 day
Plasma cortisol concentration at 8：00am
Other indicators of adrenal function
Time frame: 1 day
24h urinary，plasma catecholamines and their metabolites
24-hour urine electrolytes
Time frame: 1 day
24-hour urine potassium
Imaging of adrenal adenoma
Time frame: 1 day
unenhanced and contrast-enhanced CT of adrenal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Aldosteronism and Aldosterone-Producing Adenoma, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ping LI, MD (86-25-83-105302, li78321@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants' personal information (time frame: 1 day). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2023.