NCT07298954 Sequential Combined Versus Single-Strategy Adrenal Venous Sampling for Primary Aldosteronism(SCOPE)
| NCT ID | NCT07298954 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shumin Yang |
| Condition | Primary Aldosteronism |
| Study Type | INTERVENTIONAL |
| Enrollment | 456 participants |
| Start Date | 2025-12-25 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 456 participants in total. It began in 2025-12-25 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
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.
Contact & Investigator
Shumin Yang
STUDY CHAIR
the Chongqing Primary Aldosteronism Study (CONPASS) Group
Frequently Asked Questions
Who can join the NCT07298954 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Primary Aldosteronism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07298954 currently recruiting?
Yes, NCT07298954 is actively recruiting participants. Contact the research team at ysm@hospital.cqmu.edu.cn for enrollment information.
Where is the NCT07298954 trial being conducted?
This trial is being conducted at Chongqing, China.
Who is sponsoring the NCT07298954 clinical trial?
NCT07298954 is sponsored by Shumin Yang. The principal investigator is Shumin Yang at the Chongqing Primary Aldosteronism Study (CONPASS) Group. The trial plans to enroll 456 participants.