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Primary AldosteronismPSTAVSNCT05658705

Preoperative Supine Time for Adrenal Venous Sampling

A study testing 15-min supine time and 2-hour supine time in people with Primary Aldosteronism, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study aim to understand whether the length of preoperative supine time would affect the AVS outcome. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Primary Aldosteronism
What is being tested?
15-min supine time and 2-hour supine time
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
29 Mar 2023to 29 Mar 2025
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 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients are clinically diagnosed as primary aldosteronism with ARR≥37 (PAC showed as pg/ml, renin showed as μIU/mL) and passed through PA confirmatory tests (PAC-post CCT>110pg/ml, PAC-post SSIT >80pg/ml, or PAC-post FST>60pg/ml). PAC: plasma aldosterone concentration;
  • Patients with willing for AVS;
  • Age 18 or above, male or female, with legal capacity.

Who cannot join

  • Patients with suspected adrenocortical carcinoma or pheochromocytoma;
  • Patients with high risk of adrenal surgery;
  • Patients have been subtyping to glucocorticoid-suppressible hyperaldosteronism or familial hyperaldosteronism type III;
  • Patients were diagnosed as Cushing syndrome or subclinical Cushing syndrome;
  • Patients were treated with glucocorticoids recently;
  • Patients with whole body or venipuncture area infection;
Show all 11Show fewer
  • Patients with venous access thrombosis;
  • Patients are allergic to iodine;
  • Patients with X-ray contraindications;
  • Patients with coagulation dysfunction;
  • Patients are unable to cooperate and follow-up.

Trial locations and contacts

1 site in 1 country.

Liu Zhen jie, MD,PhD contact

86-0571-87913706

lawson4001@zju.edu.cn

China1 site, 1 recruiting

  • The second affiliated hospital of zhejiang university school of medicine

    Hangzhou, Zhejiang, 310000

    Zhejie Liu, MD,PhD, 15268135830 ext. 86, lawson3001@gmail.com

    Recruiting

Other trials in China

About this study

Official title: Preoperative Supine Time for Adrenal Venous Sampling: A Prospective Randomized Controlled Trial

This study aim to understand whether the length of preoperative supine time would affect the AVS outcome.

Read the detailed description

Primary aldosteronism (PA) is the most common form of secondary hypertension, accounting for 5% of hypertensive patients and 17-23% in patients with resistant hypertension. Compared to the primary hypertension, PA is more prone to cause severe organ damage and even early death. Adrenal venous sampling (AVS) is an effective confirmatory test for subtyping unilateral and bilateral adrenal hyperplasia, helping doctors to make an accurate decision between surgery or medication. Supine in bed before AVS is recommended for a desirable result of AVS according to guidelines. However, investigating study about the most optimal preoperative supine time before AVS is lacking. This is a single-center prospective randomized controlled study. 120 patients diagnosed as PA and with willing for further AVS examination will be included. Participants will be randomly allocated to 15-min supine time group or 2-hours supine time group. The primary outcomes are the degrees of clinical and laboratory remission (blood pressure, type and dose of antihypertensive drugs, serum potassium, orthostatic ARR). The secondary outcomes are the technical success rate and adverse event of AVS (selective index≥2 is considered as successful surgery without corticotropin stimulate). Discussion: Primary aldosteronism is an intractable public health problem, and many techniques including AVS have been developed to correctly identify this disease. This study will help to understand whether the length of preoperative supine time would affect the diagnostic efficacy of AVS, and thus help to formulate a more reasonable AVS procedure.

Being tested
15-min supine time, 2-hour supine time
Keywords
adrenal venous sampling, preoperative supine time, primary aldosteronism, resistant hypertension
Medical subject headings
Hyperaldosteronism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 15-min supine timeProcedure or surgery

    The length of preoperative supine time before AVS was 15 minutes.

  • 2-hour supine timeProcedure or surgery

    The length of preoperative supine time before AVS was 2 hours.

Study groups in NCT05658705
Study groupRoleWhat they receive
experimental group(15-min supine group)ExperimentalParticipants in the experimental group will keep supine position for 15 minutes before AVS.
Receives: Procedure: 15-min supine time
control group(2-hour supine group)Active comparatorParticipants in the control group will keep supine position for 2 hours before AVS.
Receives: Procedure: 2-hour supine time

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The rate of complete biochemical remission

    Compare the rate of complete biochemical remission between two groups. Blood was drawn to measure aldosterone, renin and potassium. According to PASO criteria, outcomes of adrenalectomy for unilateral primary aldosteronism were classified into complete, partial, and absent success, for both clinical and biochemical outcomes. The proportion of complete biochemical remission according to PASO consensus criteria.

    Measured: At 6 months of follow-up

Secondary outcomes (3)

  1. The rate of complete clinical remission

    Compare the rate of complete clinical remission between two groups. The proportion of complete clinical remission according to PASO consensus criteria. Clinical outcomes were determined by the blood pressure response to treatment and the number and dosage of antihypertensive medications.

    Measured: At 6 months of follow-up

  2. Successful catheterization rate

    Intraoperative bilateral SI value was used to judge whether the blood collection cannula was successful. In the surgery absence of osyntropin, SI≥2 was used as the standard for successful blood collection and LI≥2 was used for judging the dominant side aldosterone secretion.

    Measured: At baseline

  3. Adverse events

    Record the occurrence of adverse events, including adrenal venous hemorrhage and related adrenal insufficiency, hypertensive urgencies, anaphylactic shock, venous thrombosis, pulmonary embolism, ect.

    Measured: At 3 months of follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2022
  2. Study start29 Mar 2023
  3. Primary completion29 Mar 2025 (estimated)
  4. Study completion29 Mar 2025 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05658705
Sponsor's protocol ID
SAHZhejiangU-004
Acronym
PSTAVS
Status last verified
Apr 2024
First submitted
28 Nov 2022
Last updated
26 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Xu Z, Yang J, Hu J, Song Y, He W, Luo T, Cheng Q, Ma L, Luo R, Fuller PJ, Cai J, Li Q, Yang S; Chongqing Primary Aldosteronism Study (CONPASS) Group. Primary Aldosteronism in Patients in China With Recently Detected Hypertension. J Am Coll Cardiol. 2020 Apr 28;75(16):1913-1922. doi: 10.1016/j.jacc.2020.02.052.

    PubMed 32327102

  • Zhong S, Zhang T, He M, Yu H, Liu Z, Li Z, Song X, Xu X. Recent Advances in the Clinical Application of Adrenal Vein Sampling. Front Endocrinol (Lausanne). 2022 Feb 9;13:797021. doi: 10.3389/fendo.2022.797021. eCollection 2022.

    PubMed 35222268

  • Liu Z, He M, Song X, Xu F, Zhang B, Chen B, Yu P, Zhou H, Shan L, Wang H, Gu Z, Zhong S, Xu X, Tao Z, Chen B, Gu W. Computed tomography image fusion, Coaxial guidewire technique, Fast intraprocedural cortisol testing technique improves success rate and decreases radiation exposure, procedure time, and contrast use for adrenal vein sampling. J Hypertens. 2021 Sep 1;39(9):1918-1925. doi: 10.1097/HJH.0000000000002852.

    PubMed 34039913

  • Zennaro MC, Boulkroun S, Fernandes-Rosa FL. Pathogenesis and treatment of primary aldosteronism. Nat Rev Endocrinol. 2020 Oct;16(10):578-589. doi: 10.1038/s41574-020-0382-4. Epub 2020 Jul 28.

    PubMed 32724183

  • Funder JW, Carey RM, Mantero F, Murad MH, Reincke M, Shibata H, Stowasser M, Young WF Jr. The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016 May;101(5):1889-916. doi: 10.1210/jc.2015-4061. Epub 2016 Mar 2.

    PubMed 26934393

  • Rossi GP, Auchus RJ, Brown M, Lenders JW, Naruse M, Plouin PF, Satoh F, Young WF Jr. An expert consensus statement on use of adrenal vein sampling for the subtyping of primary aldosteronism. Hypertension. 2014 Jan;63(1):151-60. doi: 10.1161/HYPERTENSIONAHA.113.02097. Epub 2013 Nov 11.

    PubMed 24218436

  • Seccia TM, Miotto D, Battistel M, Motta R, Barisa M, Maniero C, Pessina AC, Rossi GP. A stress reaction affects assessment of selectivity of adrenal venous sampling and of lateralization of aldosterone excess in primary aldosteronism. Eur J Endocrinol. 2012 May;166(5):869-75. doi: 10.1530/EJE-11-0972. Epub 2012 Feb 13.

    PubMed 22330150

  • He M, Zhang Y, Song X, Zhang T, Yu H, Ji Y, Gong S, Chai P, Chen J, Wang S, Chen B, Xu X, Liu Z. Preoperative supine time for adrenal venous sampling: a prospective randomized controlled trial. Trials. 2024 Jan 2;25(1):14. doi: 10.1186/s13063-023-07872-2.

    PubMed 38167540

Questions about this trial

What is this clinical trial studying?

A study testing 15-min supine time and 2-hour supine time in people with Primary Aldosteronism, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 11 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 26 Apr 2024. 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 Liu Zhen jie, MD,PhD (86-0571-87913706, lawson4001@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of complete biochemical remission (time frame: At 6 months of follow-up). 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 NCT05658705, which also lists 8 linked publications.

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 26 Apr 2024.

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