Primary AldosteronismNCT06534268
Study on Postoperative Adrenal Function Assessment in Patients With Primary Aldosteronism
An observational study of Primary Aldosteronism, run by Ruijin Hospital.
Trial summary
This study employs a prospective, single-center, open, observational research design to evaluate postoperative adrenal cortical function in patients with primary aldosteronism (PA) and to explore indicators predicting postoperative adrenal insufficiency and their predictive efficacy Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Aldosteronism
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2024to 30 Jul 2026
- How long will I take part?
- 1 Year
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study intends to include 200 patients diagnosed with primary aldosteronism undergoing surgery. An ACTH stimulation test will be performed within one week postoperatively. The participants will be aged 18-75 years, with no gender restrictions. Exclusion criteria include patients using medications that affect adrenal cortical function, patients with a history of adrenal surgery, pregnant or breastfeeding women, and patients with severe underlying diseases (such as liver or kidney failure) that may affect adrenal cortical function
Who may be able to join
- Patients diagnosed with unilateral primary aldosteronism who undergo surgical treatment and have their cortical function assessed by an ACTH stimulation test within one week postoperatively.
Who cannot join
- Patients using medications that affect adrenal cortical function.
- Patients with a history of adrenal surgery
- Pregnant or breastfeeding women
- Patients with severe underlying diseases (such as liver or kidney failure) that may affect adrenal cortical function
About this study
This study employs a prospective, single-center, open, observational research design to evaluate postoperative adrenal cortical function in patients with primary aldosteronism (PA) and to explore indicators predicting postoperative adrenal insufficiency and their predictive efficacy
Read the detailed description
Patients suspected of having primary aldosteronism and admitted for treatment, who are diagnosed with primary aldosteronism through at least one confirmatory test, and subsequently diagnosed with unilateral primary aldosteronism via bilateral adrenal vein sampling and ACTH stimulation test, will undergo surgery. Those who have an ACTH stimulation test within one week postoperatively will be included in the study.
This study employs a prospective, single-center, open, observational research design to evaluate postoperative adrenal cortical function in patients with primary aldosteronism (PA) and to explore indicators predicting postoperative adrenal insufficiency and their predictive efficacy
- Conditions
- Primary Aldosteronism
- Medical subject headings
- Hyperaldosteronism
What is being measured
The primary outcome is the main question the study is designed to answer.
The gender and age of the participants
age in years and sex (female or male) of patients
Measured: 1 day
Participant's weight and height
BMI(body mess index) in kg/m^2= (weight in kg) /(height in m)^2
Measured: 1 day
Patients' baseline hormone level
serum hormone level
Measured: 1day
Number of Participants with baseline glucose metabolic levels
glucose metabolism, lipid metabolism, liver and kidney function, electrolytes, etc
Measured: 1 day
Patients' hormone levels at 0 minutes and 120 minutes after preoperative ACTH stimulation test
cortisol and aldosterone levels
Measured: 1day
Patients' hormone levels at 0 minutes and 120 minutes after postoperative ACTH stimulation test
cortisol and aldosterone levels
Measured: 1day
Number of Participants with baseline lipid metabolic levels
blood lipid levels
Measured: 1day
Patients' baseline glucose metabolic levels
0-minute、30-minute、60-minute 、120-minute and 180-minute blood glucose levels after OGTT
Measured: 1day
Number of Participants with baseline electrolytes levels
sodium, potassium, chloride, calcium, and phosphorus ion levels
Measured: 1day
Number of Participants with baseline kidney function levels
Creatinine, blood urea nitrogen (BUN), and uric acid levels
Measured: 1day
Secondary outcomes (4)
the changes of hormone levels after surgical management
cortisol and aldosterone serum hormone level
Measured: 1day
Number of Participants with changes of lipid metabolic levels after surgical management
blood lipid levels
Measured: 1day
the changes of glucose metabolic levels after surgical management
0-minute、30-minute、60-minute 、120-minute and 180-minute blood glucose levels after OGTT
Measured: 1day
Number of Participants with changes of kidney function levels after surgical management
Creatinine, blood urea nitrogen (BUN), and uric acid levels
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 posted2 Aug 2024
- Study start15 Aug 2024 (estimated)
- Primary completion15 Mar 2026 (estimated)
- Study completion30 Jul 2026 (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 Ruijin HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534268
- Sponsor's protocol ID
- RJ-PA-NEW-1
- Status last verified
- Jul 2024
- First submitted
- 27 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Postoperative Adrenal Function Assessment in Patients With Primary Aldosteronism
- ClinicalTrials.gov ID
- NCT06534268
- Acronym / sponsor ID
- RJ-PA-NEW-1
- Conditions
- Primary Aldosteronism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 2 Aug 2024 (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.
This study employs a prospective, single-center, open, observational research design to evaluate postoperative adrenal cortical function in patients with primary aldosteronism (PA) and to explore indicators predicting postoperative adrenal insufficiency and their predictive efficacy
Detailed description
Patients suspected of having primary aldosteronism and admitted for treatment, who are diagnosed with primary aldosteronism through at least one confirmatory test, and subsequently diagnosed with unilateral primary aldosteronism via bilateral adrenal vein sampling and ACTH stimulation test, will undergo surgery. Those who have an ACTH stimulation test within one week postoperatively will be included in the study.
This study employs a prospective, single-center, open, observational research design to evaluate postoperative adrenal cortical function in patients with primary aldosteronism (PA) and to explore indicators predicting postoperative adrenal insufficiency and their predictive efficacy
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study intends to include 200 patients diagnosed with primary aldosteronism undergoing surgery. An ACTH stimulation test will be performed within one week postoperatively. The participants will be aged 18-75 years, with no gender restrictions. Exclusion criteria include patients using medications that affect adrenal cortical function, patients with a history of adrenal surgery, pregnant or breastfeeding women, and patients with severe underlying diseases (such as liver or kidney failure) that may affect adrenal cortical function
Key inclusion criteria (1 listed)
- Patients diagnosed with unilateral primary aldosteronism who undergo surgical treatment and have their cortical function assessed by an ACTH stimulation test within one week postoperatively.
Key exclusion criteria (4 listed)
- Patients using medications that affect adrenal cortical function.
- Patients with a history of adrenal surgery
- Pregnant or breastfeeding women
- Patients with severe underlying diseases (such as liver or kidney failure) that may affect adrenal cortical function
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
The gender and age of the participants
Time frame: 1 day
age in years and sex (female or male) of patients
Participant's weight and height
Time frame: 1 day
BMI(body mess index) in kg/m^2= (weight in kg) /(height in m)^2
Patients' baseline hormone level
Time frame: 1day
serum hormone level
Number of Participants with baseline glucose metabolic levels
Time frame: 1 day
glucose metabolism, lipid metabolism, liver and kidney function, electrolytes, etc
Patients' hormone levels at 0 minutes and 120 minutes after preoperative ACTH stimulation test
Time frame: 1day
cortisol and aldosterone levels
Patients' hormone levels at 0 minutes and 120 minutes after postoperative ACTH stimulation test
Time frame: 1day
cortisol and aldosterone levels
Number of Participants with baseline lipid metabolic levels
Time frame: 1day
blood lipid levels
Patients' baseline glucose metabolic levels
Time frame: 1day
0-minute、30-minute、60-minute 、120-minute and 180-minute blood glucose levels after OGTT
Number of Participants with baseline electrolytes levels
Time frame: 1day
sodium, potassium, chloride, calcium, and phosphorus ion levels
Number of Participants with baseline kidney function levels
Time frame: 1day
Creatinine, blood urea nitrogen (BUN), and uric acid levels
4 secondary outcomes
the changes of hormone levels after surgical management
Time frame: 1day
Number of Participants with changes of lipid metabolic levels after surgical management
Time frame: 1day
the changes of glucose metabolic levels after surgical management
Time frame: 1day
Number of Participants with changes of kidney function levels after surgical management
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Aldosteronism, run by Ruijin Hospital.
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 1 inclusion and 4 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 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The gender and age of the participants (time frame: 1 day). The study lists 10 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 2 Aug 2024.