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

December 22, 2025 updated by: Shumin Yang

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

456

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Chongqing, China
        • Recruiting
        • The First Affilated Hospital of Chongqing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sequential combined AVS
non-ACTH-stimulated followed by ACTH-stimulated AVS
Diagnostic test: sequential combined AVS
non-ACTH-stimulated followed by ACTH-stimulated AVS
No Intervention: non-ACTH-stimulated AVS
No Intervention: ACTH-stimulated AVS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of complete biochemical remission
Time Frame: At 6 months of follow-up
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.
At 6 months of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In surgical population, the proportion of complete biochemical remission
Time Frame: At 6 months of follow-up
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.
At 6 months of follow-up
The proportion of complete clinical remission
Time Frame: At 6 months of follow-up
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.
At 6 months of follow-up
The proportion of complete biochemical response rate
Time Frame: At 6 months of follow-up
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.
At 6 months of follow-up
The proportion of complete clinical response rate
Time Frame: At 6 months of follow-up
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.
At 6 months of follow-up
Comparison of adverse events
Time Frame: At 6 months of follow-up
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.
At 6 months of follow-up
In surgical population, the proportion of complete clinical remission
Time Frame: At 6 months of follow-up
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.
At 6 months of follow-up
In medication population, the proportion of complete biochemical response rate
Time Frame: At 6 months of follow-up
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.
At 6 months of follow-up
In medication population, the proportion of complete clinical response rate
Time Frame: At 6 months of follow-up
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.
At 6 months of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shumin Yang

Collaborators

The First Affiliated Hospital of Nanchang University
The People's Hospital of Chuxiong Yi Autonomous Prefecture
First Affiliated Hospital of Kunming Medical University

Investigators

  • Study Chair: Shumin Yang, the Chongqing Primary Aldosteronism Study (CONPASS) Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 25, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

December 10, 2025

First Submitted That Met QC Criteria

December 10, 2025

First Posted (Estimated)

December 23, 2025

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 22, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCOPE PA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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