HyperaldosteronismAVSANCT03778645
Adrenal Venous Sampling Via an Antecubital Approach
An observational study of Hyperaldosteronism and Angiography, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 10 sites in China.
Trial summary
Currently, adrenal venous sampling (AVS) serves as the gold standard for subtyping of PA. Right adrenal vein catheterization is often difficult due to unfavorable anatomy of the vein including small vein size, short length, caudal direction for the transfemoral approach, and rare drainage to the accessory hepatic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperaldosteronism, Angiography
- What is being tested?
- Adrenal Venous Sampling
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- 10 sitesChina
- Study dates
- 1 Jul 2018to 31 Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with primary aldosteronism underwent AVS via antecubital approach between January 1st 2012 and December 31st 2018 in medical centers (agreement of the principal investigator to participate to the AVSA) in China
Who may be able to join
- Consent of the principal investigator to participate to the data collection of patients with primary aldosteronism underwent AVS via antecubital approach
Who cannot join
- Refusal of the principal investigator to participate to the AVSA Study
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100037
Xiongjing Jiang, MD, 86-1088322385, jxj103@hotmail.com
Hui Dong, MD
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Qifu Li, MD, +86-023-89011552
- Recruiting
The Second Hospital of Dalian Medical University
Dalian, Liaoning
Ying Zhang, MD
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Yifei Dong, MD, 86-0791-86297662
- Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
Jianling Li, MD, +8607715359553
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Jianzhong Xu, MD, 86-021-64370045, jianzhongxv@gmail.com
- Recruiting
The Eighth Affiliated Hospital of Sun Yat-sen University
Shenzhen, Guangdong
Nan Jia, MD, 86-0755-83982222, jiananchina@hotmail.com
- Recruiting
The First Affiliated Hospital of Medical College of Shihezi Universtiy
Shihezi, Xinjiang
Zhitao Yan, MD, +86-0993-2859034
- Recruiting
Xi'an NO.3 Hospital
Xi’an, Shanxi
Kang Cheng, MD, 86-029-61895566, chengkang2009@foxmail.com
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan
Min Liu, MD, +96-037165586642
About this study
Official title: Adrenal Venous Sampling Via an Antecubital Approach: A Multicenter Study
Currently, adrenal venous sampling (AVS) serves as the gold standard for subtyping of PA. Right adrenal vein catheterization is often difficult due to unfavorable anatomy of the vein including small vein size, short length, caudal direction for the transfemoral approach, and rare drainage to the accessory hepatic vein. All of these factors limit the widespread use of this approach. Given that the right adrenal vein is angled caudally in most patients, AVS via an antecubital approach was performed since January 2012. The purpose of this multicenter retrospective study was to evaluate the safety and feasibility of AVS via the antecubital approach.
Read the detailed description
Primary aldosteronism (PA) is recognized as the most common cause of secondary hypertension, with a prevalence of approximately 10% among unselected hypertensive populations. Subtype diagnosis is crucial because unilateral primary aldosteronism can be treated by laparoscopic adrenalectomy or open surgery, which may result in a cure or significant improvement of blood pressure, thus decreases the incidence of cardio-cerebrovascular complications. Currently, adrenal venous sampling (AVS) serves as the gold standard for subtyping of PA. Given that the right adrenal vein is angled caudally in most patients, AVS via an antecubital approach was performed since January 2012 at the Fuwai Hospital. So far, there have been more than fifteen hospitals to have some experience on AVS via antecubital approach with investigators' helps. The purpose of this multicenter retrospective study was to evaluate the safety and feasibility of AVS via the antecubital approach.
- Conditions
- Hyperaldosteronism, Angiography
- Being tested
- Adrenal Venous Sampling
- Keywords
- Adrenal venous sampling, Hyperaldosteronism, Angiography, Antecubital 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 SamplingProcedure or surgery
Adrenal Venous Sampling via an Antecubital Approach
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate of bilateral adrenal sampling
Measured: From January 1st 2012 to December 31st 2018
Secondary outcomes (3)
The success rate of right adrenal sampling
Measured: From January 1st 2012 to December 31st 2018
The success rate of left adrenal sampling
Measured: From January 1st 2012 to December 31st 2018
The incidence of adrenal vein ruptures occurring during AVS
Measured: From January 1st 2012 to December 31st 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Jul 2018
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiongjing Jiang, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Xiongjing Jiang, MD, Principal investigator, Fuwai Hospital, National Center for Cardiovascular Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778645
- Sponsor's protocol ID
- 2018-995
- Acronym
- AVSA
- Status last verified
- Dec 2018
- First submitted
- 15 Dec 2018
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dong H, Huang J, Zhang Y, Dong Y, Liu M, Yan Z, Li J, Chen Y, Zou Y, Wang J, Kang Y, Jiang Z, Song W, Zuo Y, Xiong H, Xu J, Jiang X. Adrenal Venous Sampling Via an Antecubital Approach in Primary Aldosteronism: A Multicenter Study. J Clin Endocrinol Metab. 2023 Dec 21;109(1):e274-e279. doi: 10.1210/clinem/dgad433.
PubMed 37466201
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adrenal Venous Sampling Via an Antecubital Approach: A Multicenter Study
- ClinicalTrials.gov ID
- NCT03778645
- Acronym / sponsor ID
- AVSA / 2018-995
- Conditions
- Hyperaldosteronism, Angiography
- Keywords
- Adrenal venous sampling, Hyperaldosteronism, Angiography, Antecubital approach
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 19 Dec 2018 (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.
Currently, adrenal venous sampling (AVS) serves as the gold standard for subtyping of PA. Right adrenal vein catheterization is often difficult due to unfavorable anatomy of the vein including small vein size, short length, caudal direction for the transfemoral approach, and rare drainage to the accessory hepatic vein. All of these factors limit the widespread use of this approach. Given that the right adrenal vein is angled caudally in most patients, AVS via an antecubital approach was performed since January 2012. The purpose of this multicenter retrospective study was to evaluate the safety and feasibility of AVS via the antecubital approach.
Detailed description
Primary aldosteronism (PA) is recognized as the most common cause of secondary hypertension, with a prevalence of approximately 10% among unselected hypertensive populations. Subtype diagnosis is crucial because unilateral primary aldosteronism can be treated by laparoscopic adrenalectomy or open surgery, which may result in a cure or significant improvement of blood pressure, thus decreases the incidence of cardio-cerebrovascular complications. Currently, adrenal venous sampling (AVS) serves as the gold standard for subtyping of PA. Given that the right adrenal vein is angled caudally in most patients, AVS via an antecubital approach was performed since January 2012 at the Fuwai Hospital. So far, there have been more than fifteen hospitals to have some experience on AVS via antecubital approach with investigators' helps. The purpose of this multicenter retrospective study was to evaluate the safety and feasibility of AVS via the antecubital approach.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with primary aldosteronism underwent AVS via antecubital approach between January 1st 2012 and December 31st 2018 in medical centers (agreement of the principal investigator to participate to the AVSA) in China
Key inclusion criteria (1 listed)
- Consent of the principal investigator to participate to the data collection of patients with primary aldosteronism underwent AVS via antecubital approach
Key exclusion criteria (1 listed)
- Refusal of the principal investigator to participate to the AVSA Study
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 SamplingAdrenal Venous Sampling via an Antecubital Approach | Procedure or surgery | – |
Primary outcome
The success rate of bilateral adrenal sampling
Time frame: From January 1st 2012 to December 31st 2018
3 secondary outcomes
The success rate of right adrenal sampling
Time frame: From January 1st 2012 to December 31st 2018
The success rate of left adrenal sampling
Time frame: From January 1st 2012 to December 31st 2018
The incidence of adrenal vein ruptures occurring during AVS
Time frame: From January 1st 2012 to December 31st 2018
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2018.
- Derived from this study: PubMed 37466201Dong H, Huang J, Zhang Y, Dong Y, Liu M, Yan Z, Li J, Chen Y, Zou Y, Wang J, Kang Y, Jiang Z, Song W, Zuo Y, Xiong H, Xu J, Jiang X. Adrenal Venous Sampling Via an Antecubital Approach in Primary Aldosteronism: A Multicenter Study. J Clin Endocrinol Metab. 2023 Dec 21;109(1):e274-e279. doi: 10.1210/clinem/dgad433.
- Individual participant dataSharing planned: No
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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.
Xiongjing Jiang, MD principal investigator
Fuwai Hospital, National Center for Cardiovascular Disease
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperaldosteronism and Angiography, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 10 sites 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 1 inclusion and 1 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 21 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 Xiongjing Jiang, MD (+861088322385, jxj103@hotmail.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 sampling (time frame: From January 1st 2012 to December 31st 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03778645, which also lists 1 linked publication.
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 21 Dec 2018.