HyperaldosteronismAFAVSNCT06029803
Antecubital Versus Femoral Approach for Adrenal Venous Sampling
A study testing Adrenal Venous Sampling via Antecubital Approach and Adrenal Venous Sampling via Femoral Approach in people with Hyperaldosteronism, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
Subtype diagnosis is crucial for the treatment of primary aldosteronism (PA), which conducts the appropriate treatment strategy. Currently, adrenal venous sampling (AVS) serves as the gold standard for subtyping of PA. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hyperaldosteronism
- What is being tested?
- Adrenal Venous Sampling via Antecubital Approach and Adrenal Venous Sampling via Femoral Approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 30 Nov 2023
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged from 18 to 60 with no limits in sex;
- Patients with confirmed primary aldosteronism;
- Patients or their legal representatives sign written informed consent approved by the ethics committee
Who cannot join
- Severe comorbidity, including stroke, myocardial infarction, heart failure, severe valvular heart disease, liver cirrhosis, and metastatic tumor within the previous 3 months；
- An estimated glomerular filtration rate <45 ml/min/1.73 m2, or serum creatinine >176 μmol/L；
- Patients who refuse adrenalectomy;
- suspected of having an adrenocortical carcinoma;
- allergy to contrast agent;
- pregnant, nursing, or planning to become pregnant
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100037
Hui Dong, MD, 86-010-88322387, donghui666@sina.com
Hui Dong, MD
About this study
Official title: Antecubital Versus Femoral Approach for Adrenal Venous Sampling: A Randomised Controlled Trial
Subtype diagnosis is crucial for the treatment of primary aldosteronism (PA), which conducts the appropriate treatment strategy. Currently, adrenal venous sampling (AVS) serves as the gold standard for subtyping of PA. At present, almost all medical centers use the femoral vein approach for AVS, and most studies report that the success rate is 30%-80%. Our research team is the first in the world to conduct AVS via an antecubital approach. The aim of this study is to compare the success rate and safety of AVS via antecubital and femoral approach.
Read the detailed description
Primary aldosteronism (PA) is one of the most common causes of secondary hypertension, and its most common subtypes are aldosterone-producing adenoma and idiopathic hyperaldosteronism, which account for 95% to 98% of PA. Subtype diagnosis is crucial for the treatment of primary aldosteronism, which conducts the appropriate treatment strategy. Currently, adrenal venous sampling (AVS) serves as the gold standard for subtyping of PA. At present, almost all medical centers use the femoral vein approach for AVS, and most studies report that the success rate is 30%-80%.How to improve the success rate of AVS has been a hot topic in the field of primary aldosteronism. Our research team is the first in the world to conduct AVS via an antecubital approach. The previous study found that the success rate of AVS via this approach can reach to 88.0%, with a low incidence of complications. In this study, patients with primary aldosteronism who meet the indications of AVS will be randomly assigned to antecubital approach group and femoral approach group. Clinical, laboratory and examination data will be recorded and the success rate and safety of AVS via antecubital and femoral approach will be compared.
- Conditions
- Hyperaldosteronism
- Being tested
- Adrenal Venous Sampling via Antecubital Approach, Adrenal Venous Sampling via Femoral Approach
- Keywords
- Adrenal venous sampling, Hyperaldosteronism, Antecubital approach, Femoral approach
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adrenal Venous Sampling via Antecubital ApproachProcedure or surgery
Patients assigned to the antecubital approach group (experimental group) will undergo AVS via antecubital approach.A 5F introducer sheath will be introduced into the antecubital vein. After heparinization,a diagnostic catheter with side holes will be introduced. Two blood samples (about 4mL each) will be collected from the inferior vena cava, right adrenal vein and left adrenal vein for the determination of cortisol and aldosterone concentrations.
Adrenal Venous Sampling via Femoral ApproachProcedure or surgery
Patients assigned to the femoral approach group (active comparator group) will undergo AVS via femoral vein approach.The introducer sheath will be introduced into the femoral vein.Two blood samples (about 4mL each) will be collected from the inferior vena cava, right adrenal vein and left adrenal vein for the determination of cortisol and aldosterone concentrations.
| Study group | Role | What they receive |
|---|---|---|
| Adrenal Venous Sampling via Antecubital Approach | Experimental | Patients in the experimental group will undergo adrenal venous sampling via antecubital vein approach. Receives: Procedure: Adrenal Venous Sampling via Antecubital Approach |
| Adrenal Venous Sampling via Femoral Approach | Active comparator | Patients in the active comparator group will undergo adrenal venous sampling via femoral vein approach. Receives: Procedure: Adrenal Venous Sampling via Femoral Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate of bilateral adrenal venous sampling
Successful sampling will be defined by high selectivity index (cortisol in the adrenal vein/cortisol in inferior vena cava >2 without ACTH simulation)
Measured: At AVS procedure
Secondary outcomes (8)
The success rate of left adrenal venous sampling
Successful sampling will be defined by high selectivity index (cortisol in the adrenal vein/cortisol in inferior vena cava >2 without ACTH simulation)
Measured: At AVS procedure
The success rate of right adrenal venous sampling
Successful sampling will be defined by high selectivity index (cortisol in the adrenal vein/cortisol in inferior vena cava >2 without ACTH simulation)
Measured: At AVS procedure
Selection of intraoperative catheter
Catheter selection
Measured: At AVS procedure
Time of the procedure
Time of the procedure
Measured: At AVS procedure
Time of fluoroscopy
Time of fluoroscopy
Measured: At AVS procedure
The contrast agent dosage
The contrast agent dosage
Measured: At AVS procedure
the incidence of complications
Complications related to adrenal vein cannulations (adrenal vein hematoma, inferior vena cava dissection, puncture site hematoma, etc)
Measured: 1 week after AVS procedure
the cost of the procedure
the cost of the procedure
Measured: At AVS procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start1 Apr 2022
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperaldosteronismStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui DONG, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Hui Dong, MD, Principal investigator, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029803
- Sponsor's protocol ID
- 2022-1715
- Acronym
- AFAVS
- Status last verified
- Sep 2023
- First submitted
- 26 Aug 2023
- Last updated
- 8 Sep 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 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antecubital Versus Femoral Approach for Adrenal Venous Sampling: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06029803
- Acronym / sponsor ID
- AFAVS / 2022-1715
- Conditions
- Hyperaldosteronism
- Keywords
- Adrenal venous sampling, Hyperaldosteronism, Antecubital approach, Femoral approach
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 8 Sep 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.
Subtype diagnosis is crucial for the treatment of primary aldosteronism (PA), which conducts the appropriate treatment strategy. Currently, adrenal venous sampling (AVS) serves as the gold standard for subtyping of PA. At present, almost all medical centers use the femoral vein approach for AVS, and most studies report that the success rate is 30%-80%. Our research team is the first in the world to conduct AVS via an antecubital approach. The aim of this study is to compare the success rate and safety of AVS via antecubital and femoral approach.
Detailed description
Primary aldosteronism (PA) is one of the most common causes of secondary hypertension, and its most common subtypes are aldosterone-producing adenoma and idiopathic hyperaldosteronism, which account for 95% to 98% of PA. Subtype diagnosis is crucial for the treatment of primary aldosteronism, which conducts the appropriate treatment strategy. Currently, adrenal venous sampling (AVS) serves as the gold standard for subtyping of PA. At present, almost all medical centers use the femoral vein approach for AVS, and most studies report that the success rate is 30%-80%.How to improve the success rate of AVS has been a hot topic in the field of primary aldosteronism. Our research team is the first in the world to conduct AVS via an antecubital approach. The previous study found that the success rate of AVS via this approach can reach to 88.0%, with a low incidence of complications. In this study, patients with primary aldosteronism who meet the indications of AVS will be randomly assigned to antecubital approach group and femoral approach group. Clinical, laboratory and examination data will be recorded and the success rate and safety of AVS via antecubital and femoral approach will be compared.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adrenal Venous Sampling via Antecubital Approach | Experimental | Procedure: Adrenal Venous Sampling via Antecubital ApproachPatients in the experimental group will undergo adrenal venous sampling via antecubital vein approach. |
| Adrenal Venous Sampling via Femoral Approach | Active comparator | Procedure: Adrenal Venous Sampling via Femoral ApproachPatients in the active comparator group will undergo adrenal venous sampling via femoral vein approach. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged from 18 to 60 with no limits in sex;
- Patients with confirmed primary aldosteronism;
- Patients or their legal representatives sign written informed consent approved by the ethics committee
Key exclusion criteria (6 listed)
- Severe comorbidity, including stroke, myocardial infarction, heart failure, severe valvular heart disease, liver cirrhosis, and metastatic tumor within the previous 3 months；
- An estimated glomerular filtration rate <45 ml/min/1.73 m2, or serum creatinine >176 μmol/L；
- Patients who refuse adrenalectomy;
- suspected of having an adrenocortical carcinoma;
- allergy to contrast agent;
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 |
|---|---|---|
| Adrenal Venous Sampling via Antecubital ApproachPatients assigned to the antecubital approach group (experimental group) will undergo AVS via antecubital approach.A 5F introducer sheath will be introduced into the antecubital vein. After heparinization,a diagnostic catheter with side holes will be introduced. Two blood samples (about 4mL each) will be collected from the inferior vena cava, right adrenal vein and left adrenal vein for the determination of cortisol and aldosterone concentrations. | Procedure or surgery | Adrenal Venous Sampling via Antecubital Approach |
| Adrenal Venous Sampling via Femoral ApproachPatients assigned to the femoral approach group (active comparator group) will undergo AVS via femoral vein approach.The introducer sheath will be introduced into the femoral vein.Two blood samples (about 4mL each) will be collected from the inferior vena cava, right adrenal vein and left adrenal vein for the determination of cortisol and aldosterone concentrations. | Procedure or surgery | Adrenal Venous Sampling via Femoral Approach |
Primary outcome
The success rate of bilateral adrenal venous sampling
Time frame: At AVS procedure
Successful sampling will be defined by high selectivity index (cortisol in the adrenal vein/cortisol in inferior vena cava >2 without ACTH simulation)
8 secondary outcomes
The success rate of left adrenal venous sampling
Time frame: At AVS procedure
The success rate of right adrenal venous sampling
Time frame: At AVS procedure
Selection of intraoperative catheter
Time frame: At AVS procedure
Time of the procedure
Time frame: At AVS procedure
Time of fluoroscopy
Time frame: At AVS procedure
The contrast agent dosage
Time frame: At AVS procedure
the incidence of complications
Time frame: 1 week after AVS procedure
the cost of the procedure
Time frame: At AVS procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 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.
Hui Dong, MD principal investigator
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adrenal Venous Sampling via Antecubital Approach and Adrenal Venous Sampling via Femoral Approach in people with Hyperaldosteronism, run by Chinese Academy of Medical Sciences, Fuwai Hospital 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 8 Sep 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 Hui Dong, MD (86-010-88322387, donghui666@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The success rate of bilateral adrenal venous sampling (time frame: At AVS procedure). 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 8 Sep 2023.