Primary AldosteronismNCT06737848
The Comparison of Single Catheter and Double Catheter Adrenal Vein Sampling Methods Based on the Upper Limb Approach
A study testing Single catheter adrenal vein sampling and Double catheters adrenal vein sampling in people with Primary Aldosteronism, run by Army Medical University, China.
Trial summary
Primary Aldosteronism (PA) is a clinical syndrome characterized by the autonomous overproduction of aldosterone by the adrenal cortex's zona glomerulosa, leading to hypertension, elevated aldosterone levels, and suppressed renin activity as the primary manifestations. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Aldosteronism
- What is being tested?
- Single catheter adrenal vein sampling and Double catheters adrenal vein sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-70 years with hypertension.
- Initial screening shows a standing aldosterone/renin ratio (ARR) > 3.7, a baseline aldosterone level > 10 ng/dl, aldosterone level > 6 ng/dl after a saline load test, or aldosterone decrease of less than 30% after a captopril suppression test, consistent with a diagnosis of primary aldosteronism.
- Voluntary participation in the trial, with signed informed consent.
Who cannot join
- Patients with an allergy to iodinated contrast agents.
- Patients who are pregnant, breastfeeding, or planning to become pregnant.
- Patients with severe comorbidities, such as renal failure, liver cirrhosis, metastatic tumors, or those who have had an acute stroke or acute myocardial infarction, as well as patients with a history of surgery within the past month.
- Patients suspected of having adrenal cortical carcinoma.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Primary Aldosteronism (PA) is a clinical syndrome characterized by the autonomous overproduction of aldosterone by the adrenal cortex's zona glomerulosa, leading to hypertension, elevated aldosterone levels, and suppressed renin activity as the primary manifestations. Studies have shown that the prevalence of PA in an unselected hypertensive population ranges from 5% to 11% , while the prevalence in patients with resistant hypertension is approximately 20% . PA is one of the most common causes of secondary hypertension , and its prevalence increases with rising blood pressure levels. Due to the adverse effects of PA on the heart, arterial walls, and kidneys, it contributes to the occurrence of cardiovascular events, with atrial fibrillation being the most common . In summary, PA is characterized by rapid onset, significant symptoms, obscurity, and severe complications, making early diagnosis and targeted treatment essential for prevention.
This study aims to explore a quasi-selected prospective randomized controlled method to compare the clinical efficacy differences between single-catheter and dual-catheter adrenal sampling via the right upper limb approach. The study seeks to clarify the effectiveness and safety of single-catheter sampling from the upper limb, providing a more efficient and cost-effective solution for the subtype diagnosis of patients with Primary Aldosteronism (PA).
- Conditions
- Primary Aldosteronism
- Being tested
- Single catheter adrenal vein sampling, Double catheters adrenal vein sampling
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single catheter adrenal vein samplingProcedure or surgery
The clinical invasive procedure involves inserting a single catheter into the right and left adrenal veins to collect blood samples from both adrenal veins.
Double catheters adrenal vein samplingProcedure or surgery
The clinical invasive procedure involves inserting double catheters into the right and left adrenal veins to collect blood samples from both adrenal veins.
| Study group | Role | What they receive |
|---|---|---|
| Single Catheter Adrenal Vein Sampling | Experimental | Patients in the Intervention group will utilize a multifunctional catheter for bilateral adrenal vein sampling. Receives: Procedure: Single catheter adrenal vein sampling |
| Double Catheter Adrenal Vein Sampling | Active comparator | Patients in this group will utilize two catheters for bilateral adrenal vein sampling. Receives: Procedure: Double catheters adrenal vein sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of left-sided adrenal vein sampling between two groups
Biochemical analysis of puncture-point blood samples: A selection index (SI) ≥ 2, defined as the ratio of adrenal plasma cortisol concentration (PCC) to peripheral PCC, indicates successful unilateral aldosterone venous sampling (AVS).
Measured: 7 month(End of Trial)
Secondary outcomes (4)
Change of material costs between two groups
Measured: 7 month(End of Trial)
Change of average operation time of left-side adrenal vein sampling between two groups
The surgical doctor will record the operation time for adrenal vein sampling from the left adrenal vein and compare change of the average operation time between the two groups at end of the study.
Measured: 7 month(End of Trial)
Change of average fluoroscopy time of adrenal vein sampling between two groups
Change of average fluoroscopy time of adrenal vein sampling between two groups at the end of the study.
Measured: 7 month(End of Trial)
Change of the surgical supplies cost between two groups
Change of the surgical supplies cost between two groups at the end of the study.
Measured: 7 month(End of Trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start30 Dec 2024 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion31 Jul 2025 (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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Army Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Li, Army Medical University, China
- Investigators
- Li Li, MD, Study director, Army Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737848
- Sponsor's protocol ID
- AMCIIT241106
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Single Catheter and Double Catheter Adrenal Vein Sampling Methods Based on the Upper Limb Approach
- ClinicalTrials.gov ID
- NCT06737848
- Acronym / sponsor ID
- AMCIIT241106
- Conditions
- Primary Aldosteronism
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Army Medical University, ChinaUniversity, hospital or other
- Study start
- 30 Dec 2024 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 17 Dec 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.
Primary Aldosteronism (PA) is a clinical syndrome characterized by the autonomous overproduction of aldosterone by the adrenal cortex's zona glomerulosa, leading to hypertension, elevated aldosterone levels, and suppressed renin activity as the primary manifestations. Studies have shown that the prevalence of PA in an unselected hypertensive population ranges from 5% to 11% , while the prevalence in patients with resistant hypertension is approximately 20% . PA is one of the most common causes of secondary hypertension , and its prevalence increases with rising blood pressure levels. Due to the adverse effects of PA on the heart, arterial walls, and kidneys, it contributes to the occurrence of cardiovascular events, with atrial fibrillation being the most common . In summary, PA is characterized by rapid onset, significant symptoms, obscurity, and severe complications, making early diagnosis and targeted treatment essential for prevention.
This study aims to explore a quasi-selected prospective randomized controlled method to compare the clinical efficacy differences between single-catheter and dual-catheter adrenal sampling via the right upper limb approach. The study seeks to clarify the effectiveness and safety of single-catheter sampling from the upper limb, providing a more efficient and cost-effective solution for the subtype diagnosis of patients with Primary Aldosteronism (PA).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Catheter Adrenal Vein Sampling | Experimental | Procedure: Single catheter adrenal vein samplingPatients in the Intervention group will utilize a multifunctional catheter for bilateral adrenal vein sampling. |
| Double Catheter Adrenal Vein Sampling | Active comparator | Procedure: Double catheters adrenal vein samplingPatients in this group will utilize two catheters for bilateral adrenal vein sampling. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18-70 years with hypertension.
- Initial screening shows a standing aldosterone/renin ratio (ARR) > 3.7, a baseline aldosterone level > 10 ng/dl, aldosterone level > 6 ng/dl after a saline load test, or aldosterone decrease of less than 30% after a captopril suppression test, consistent with a diagnosis of primary aldosteronism.
- Voluntary participation in the trial, with signed informed consent.
Key exclusion criteria (4 listed)
- Patients with an allergy to iodinated contrast agents.
- Patients who are pregnant, breastfeeding, or planning to become pregnant.
- Patients with severe comorbidities, such as renal failure, liver cirrhosis, metastatic tumors, or those who have had an acute stroke or acute myocardial infarction, as well as patients with a history of surgery within the past month.
- Patients suspected of having adrenal cortical carcinoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single catheter adrenal vein samplingThe clinical invasive procedure involves inserting a single catheter into the right and left adrenal veins to collect blood samples from both adrenal veins. | Procedure or surgery | Single Catheter Adrenal Vein Sampling |
| Double catheters adrenal vein samplingThe clinical invasive procedure involves inserting double catheters into the right and left adrenal veins to collect blood samples from both adrenal veins. | Procedure or surgery | Double Catheter Adrenal Vein Sampling |
Primary outcome
Success rate of left-sided adrenal vein sampling between two groups
Time frame: 7 month(End of Trial)
Biochemical analysis of puncture-point blood samples: A selection index (SI) ≥ 2, defined as the ratio of adrenal plasma cortisol concentration (PCC) to peripheral PCC, indicates successful unilateral aldosterone venous sampling (AVS).
4 secondary outcomes
Change of material costs between two groups
Time frame: 7 month(End of Trial)
Change of average operation time of left-side adrenal vein sampling between two groups
Time frame: 7 month(End of Trial)
Change of average fluoroscopy time of adrenal vein sampling between two groups
Time frame: 7 month(End of Trial)
Change of the surgical supplies cost between two groups
Time frame: 7 month(End of Trial)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: No
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Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension
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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.
Li Li, MD study director
Army Medical University, China
Questions about this trial
What is this clinical trial studying?
A study testing Single catheter adrenal vein sampling and Double catheters adrenal vein sampling in people with Primary Aldosteronism, run by Army Medical University, 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 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: opening soon, as of the sponsor's last update on 17 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Li,MD (13372683559, doublepear@tmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of left-sided adrenal vein sampling between two groups (time frame: 7 month(End of Trial)). 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 17 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.