Comparing sequential combined and single adrenal venous sampling approaches for primary aldosteronism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, randomized controlled trial that will enroll adults with confirmed primary aldosteronism and randomize them 1:1:1 to sequential combined AVS (non‑ACTH followed by ACTH), non‑ACTH AVS alone, or ACTH‑stimulated AVS alone. AVS results will guide clinical management decisions (surgical adrenalectomy versus medical therapy), and patients will be followed to measure clinical outcomes. The primary endpoint is treatment response rate at 6 months post‑treatment, compared across the three groups. The trial is led by the First Affiliated Hospital of Chongqing Medical University with three collaborating centers in China.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Shumin Yang
• Email: ysm@hospital.cqmu.edu.cn
• Phone: +86 023-89011552

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.