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Primary AldosteronismNCT07298954

Sequential Combined Versus Single-Strategy Adrenal Venous Sampling for Primary Aldosteronism(SCOPE)

A study testing sequential combined AVS in people with Primary Aldosteronism, run by Shumin Yang at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is a prospective, multicenter, randomized clinical trial aimed to compare the impact of three AVS diagnostic strategies on the clinical outcomes of patients with primary aldosteronism. 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?
sequential combined AVS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
456 participants
Where
1 siteChina
Study dates
25 Dec 2025to 31 Dec 2028
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

  • Fully understand the study process, voluntarily agree to participate, and sign informed consent.
  • Diagnosed with primary aldosteronism. # Age 18-70 years with hypertension, any sex.

Who cannot join

  • Patients for whom AVS can be bypassed: Typical BPA (normal serum potassium and plasma aldosterone concentration (PAC) < 110 pg/mL, eligible for direct medical therapy); Typical UPA (PAC ≥ 200 pg/mL, plasma renin concentration (PRC) ≤ 5 μIU/mL, spontaneous hypokalemia, unilateral adrenal adenoma ≥ 1 cm with normal contralateral adrenal on CT or 68Ga-Pentixafor PET-CT indicating unilateral functional tumor, eligible for direct surgery);
  • Refusal of AVS or surgery, or contraindication to surgery.
  • Allergy to ACTH or contrast agents.
  • Combined with autonomous cortisol secretion (1 mg overnight dexamethasone suppression test cortisol ≥ 50 nmol/L).
  • Early-onset hypertension (<20 years) with hypokalemia and family history, suggestive of familial hyperaldosteronism or Liddle syndrome.
  • Imaging cannot exclude pheochromocytoma or adrenocortical carcinoma (nodule ≥ 4 cm, CT ≥ 20 HU, or MRI suggestive).
Show all 12Show fewer
  • Active malignancy.
  • Previous adrenal surgery.
  • Chronic glucocorticoid use that cannot be discontinued.
  • Adrenal insufficiency requiring hormone replacement.
  • Pregnancy or breastfeeding; history of alcohol or substance abuse, or inability to cooperate due to psychiatric disorders.
  • NYHA class III-IV heart failure or hospitalization for worsening heart failure in the past 3 months, stroke or acute coronary syndrome in past 3 months, severe anemia (Hb < 60 g/L), severe liver or renal disease (ALT ≥ 3×upper limit; eGFR <30 mL/min/1.73 m2 or dialysis), systemic inflammatory response syndrome (SIRS), poorly controlled diabetes (FBG ≥ 13.3 mmol/L), severe obesity (BMI ≥ 35 kg/m2), untreated aneurysm, or other conditions severely interfering with study participation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • The First Affilated Hospital of Chongqing Medical University

    Chongqing

    Shumin Yang, +86 023-89011552, ysm@hospital.cqmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Sequential Combined Versus Single-Strategy Adrenal Venous Sampling for Primary Aldosteronism: A Multicenter, Randomized Trial

This study is a prospective, multicenter, randomized clinical trial aimed to compare the impact of three AVS diagnostic strategies on the clinical outcomes of patients with primary aldosteronism. The strategies include sequential combined AVS (non-ACTH-stimulated followed by ACTH-stimulated AVS), non- ACTH-stimulated AVS alone, and ACTH-stimulated AVS alone. The findings of this study will provide critical evidence for the clinical practice standards of AVS.

Read the detailed description

This is a prospective, multicenter, randomized controlled clinical trial. This study will be led by the First Affiliated Hospital of Chongqing Medical University, with Chuxiong Yi Autonomous Prefecture People's Hospital, the First Affiliated Hospital of Kunming Medical University, and the First Affiliated Hospital of Nanchang Medical University serving as collaborating centers. According to the inclusion and exclusion criteria, eligible patients with confirmed primary aldosteronism (PA) will be enrolled and randomly assigned in a 1:1:1 ratio to one of the following groups: sequential combined AVS, non-ACTH-stimulated AVS alone, and ACTH-stimulated AVS alone. These stratifications will guide clinical treatment decisions, either surgical therapy or medical therapy, and patients will be followed to evaluate their clinical outcomes. The primary outcome is the treatment response rate at 6-month follow-up, which will be compared among the three groups.

Being tested
sequential combined AVS
Keywords
Primary Aldosteronism, Adrenal venous sampling, sequential combined AVS, non-ACTH-stimulated, ACTH-stimulated AVS, complete biochemical remission rate
Medical subject headings
Hyperaldosteronism

What participants receive

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

  • sequential combined AVSDiagnostic test

    non-ACTH-stimulated followed by ACTH-stimulated AVS

Study groups in NCT07298954
Study groupRoleWhat they receive
sequential combined AVSExperimentalnon-ACTH-stimulated followed by ACTH-stimulated AVS
Receives: Diagnostic Test: sequential combined AVS
non-ACTH-stimulated AVSNo interventionnon-ACTH-stimulated AVS
ACTH-stimulated AVSNo interventionACTH-stimulated AVS

What is being measured

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

  1. The proportion of complete biochemical remission

    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 (8)
  1. The proportion of complete clinical remission

    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 clinical remission according to PASO consensus criteria.

    Measured: At 6 months of follow-up

  2. The proportion of complete biochemical response rate

    Blood was drawn to measure aldosterone, renin and potassium.According to PAMO criteria, outcomes of medication for bilateral primary aldosteronism were classified into complete, partial, and absent response, for both clinical and biochemical outcomes.The proportion of complete biochemical response according to PAMO consensus criteria.

    Measured: At 6 months of follow-up

  3. The proportion of complete clinical response rate

    Blood was drawn to measure aldosterone, renin and potassium.According to PAMO criteria, outcomes of medication for bilateral primary aldosteronism were classified into complete, partial, and absent response, for both clinical and biochemical outcomes.The proportion of complete clinical response according to PAMO consensus criteria.

    Measured: At 6 months of follow-up

  4. Comparison of adverse events

    The occurrence of adverse events was recorded, including adrenal vein rupture, peripheral puncture site complications including femoral vein thrombosis, puncture site hematoma, ACTH allergy, and anaphylactic shock., etc.

    Measured: At 6 months of follow-up

  5. In surgical population, the proportion of complete biochemical remission

    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

  6. In surgical population, the proportion of complete clinical remission

    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 clinical remission according to PASO consensus criteria.

    Measured: At 6 months of follow-up

  7. In medication population, the proportion of complete biochemical response rate

    Blood was drawn to measure aldosterone, renin and potassium.According to PAMO criteria, outcomes of medication for bilateral primary aldosteronism were classified into complete, partial, and absent response, for both clinical and biochemical outcomes.The proportion of complete biochemical response according to PAMO consensus criteria.

    Measured: At 6 months of follow-up

  8. In medication population, the proportion of complete clinical response rate

    Blood was drawn to measure aldosterone, renin and potassium.According to PAMO criteria, outcomes of medication for bilateral primary aldosteronism were classified into complete, partial, and absent response, for both clinical and biochemical outcomes.The proportion of complete clinical response according to PAMO consensus criteria.

    Measured: At 6 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 posted23 Dec 2025
  2. Study start25 Dec 2025 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2028 (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
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
456 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07298954
Sponsor's protocol ID
SCOPE PA
Status last verified
Dec 2025
First submitted
10 Dec 2025
Last updated
24 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Monticone S, Burrello J, Tizzani D, Bertello C, Viola A, Buffolo F, Gabetti L, Mengozzi G, Williams TA, Rabbia F, Veglio F, Mulatero P. Prevalence and Clinical Manifestations of Primary Aldosteronism Encountered in Primary Care Practice. J Am Coll Cardiol. 2017 Apr 11;69(14):1811-1820. doi: 10.1016/j.jacc.2017.01.052.

    PubMed 28385310
  • Rossi GP, Bernini G, Caliumi C, Desideri G, Fabris B, Ferri C, Ganzaroli C, Giacchetti G, Letizia C, Maccario M, Mallamaci F, Mannelli M, Mattarello MJ, Moretti A, Palumbo G, Parenti G, Porteri E, Semplicini A, Rizzoni D, Rossi E, Boscaro M, Pessina AC, Mantero F; PAPY Study Investigators. A prospective study of the prevalence of primary aldosteronism in 1,125 hypertensive patients. J Am Coll Cardiol. 2006 Dec 5;48(11):2293-300. doi: 10.1016/j.jacc.2006.07.059. Epub 2006 Nov 13.

    PubMed 17161262
  • 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
  • Libianto R, Russell GM, Stowasser M, Gwini SM, Nuttall P, Shen J, Young MJ, Fuller PJ, Yang J. Detecting primary aldosteronism in Australian primary care: a prospective study. Med J Aust. 2022 May 2;216(8):408-412. doi: 10.5694/mja2.51438. Epub 2022 Feb 25.

    PubMed 35218017
  • Mulatero P, Sechi LA, Williams TA, Lenders JWM, Reincke M, Satoh F, Januszewicz A, Naruse M, Doumas M, Veglio F, Wu VC, Widimsky J. Subtype diagnosis, treatment, complications and outcomes of primary aldosteronism and future direction of research: a position statement and consensus of the Working Group on Endocrine Hypertension of the European Society of Hypertension. J Hypertens. 2020 Oct;38(10):1929-1936. doi: 10.1097/HJH.0000000000002520.

    PubMed 32890265
  • Hundemer GL, Curhan GC, Yozamp N, Wang M, Vaidya A. Renal Outcomes in Medically and Surgically Treated Primary Aldosteronism. Hypertension. 2018 Sep;72(3):658-666. doi: 10.1161/HYPERTENSIONAHA.118.11568.

    PubMed 29987110
  • 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
  • Song Y, Yang J, Shen H, Ng E, Fuller PJ, Feng Z, Hu J, Ma L, Yang Y, Du Z, Wang Y, Luo T, He W, Li Q, Wu FF, Yang S; represent for the Chongqing Primary Aldosteronism Study (CONPASS) Group. Development and validation of model for sparing adrenal venous sampling in diagnosing unilateral primary aldosteronism. J Hypertens. 2022 Sep 1;40(9):1692-1701. doi: 10.1097/HJH.0000000000003197. Epub 2022 Jul 22.

    PubMed 35881462
  • Adler GK, Stowasser M, Correa RR, Khan N, Kline G, McGowan MJ, Mulatero P, Murad MH, Touyz RM, Vaidya A, Williams TA, Yang J, Young WF, Zennaro MC, Brito JP. Primary Aldosteronism: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2025 Aug 7;110(9):2453-2495. doi: 10.1210/clinem/dgaf284.

    PubMed 40658480
  • Chee NYN, Abdul-Wahab A, Libianto R, Gwini SM, Doery JCG, Choy KW, Chong W, Lau KK, Lam Q, MacIsaac RJ, Chiang C, Shen J, Young MJ, Fuller PJ, Yang J. Utility of adrenocorticotropic hormone in adrenal vein sampling despite the occurrence of discordant lateralization. Clin Endocrinol (Oxf). 2020 Oct;93(4):394-403. doi: 10.1111/cen.14220. Epub 2020 Jun 15.

    PubMed 32403203
  • Elliott P, Holmes DT. Adrenal vein sampling: substantial need for technical improvement at regional referral centres. Clin Biochem. 2013 Oct;46(15):1399-404. doi: 10.1016/j.clinbiochem.2013.04.004. Epub 2013 Apr 16.

    PubMed 23603377
  • Laurent I, Astere M, Zheng F, Chen X, Yang J, Cheng Q, Li Q. Adrenal venous sampling with or without adrenocorticotropic hormone stimulation: A meta-analysis. J Clin Endocrinol Metab. 2018 Nov 6. doi: 10.1210/jc.2018-01324. Online ahead of print.

    PubMed 30403797
  • Monticone S, Satoh F, Giacchetti G, Viola A, Morimoto R, Kudo M, Iwakura Y, Ono Y, Turchi F, Paci E, Veglio F, Boscaro M, Rainey W, Ito S, Mulatero P. Effect of adrenocorticotropic hormone stimulation during adrenal vein sampling in primary aldosteronism. Hypertension. 2012 Apr;59(4):840-6. doi: 10.1161/HYPERTENSIONAHA.111.189548. Epub 2012 Feb 13.

    PubMed 22331382
  • Rossi GP, Pitter G, Bernante P, Motta R, Feltrin G, Miotto D. Adrenal vein sampling for primary aldosteronism: the assessment of selectivity and lateralization of aldosterone excess baseline and after adrenocorticotropic hormone (ACTH) stimulation. J Hypertens. 2008 May;26(5):989-97. doi: 10.1097/HJH.0b013e3282f9e66a.

    PubMed 18398342
  • Rossi GP, Ganzaroli C, Miotto D, De Toni R, Palumbo G, Feltrin GP, Mantero F, Pessina AC. Dynamic testing with high-dose adrenocorticotrophic hormone does not improve lateralization of aldosterone oversecretion in primary aldosteronism patients. J Hypertens. 2006 Feb;24(2):371-9. doi: 10.1097/01.hjh.0000202818.10459.96.

    PubMed 16508586

Questions about this trial

What is this clinical trial studying?

A study testing sequential combined AVS in people with Primary Aldosteronism, run by Shumin Yang 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 2 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 24 Dec 2025. 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?

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 Shumin Yang (+86 023-89011552, ysm@hospital.cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion 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 NCT07298954, which also lists 25 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 24 Dec 2025; AzTrials last refreshed its copy on 1 Nov 2026.

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