Comparing sequential combined and single adrenal venous sampling approaches for primary aldosteronism
Sequential Combined Versus Single-Strategy Adrenal Venous Sampling for Primary Aldosteronism: A Multicenter, Randomized Trial
This study will see if three adrenal venous sampling approaches—sequential combined (non‑ACTH then ACTH), non‑ACTH alone, and ACTH‑stimulated alone—lead to better 6‑month treatment outcomes for adults aged 18–70 with primary aldosteronism.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 456 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Chongqing Medical University Academic / other |
| Locations | 1 site (Chongqing) |
| Trial ID | NCT07298954 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–70 with confirmed primary aldosteronism who can undergo AVS and provide informed consent are the intended participants.
Not a fit: Patients who already qualify for direct medical therapy or direct unilateral surgery without needing AVS, those allergic to ACTH or contrast agents, or those with contraindications to surgery are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the trial could identify the AVS approach that improves treatment decisions and clinical outcomes for patients with primary aldosteronism.
How similar studies have performed: Previous work has compared ACTH‑stimulated and non‑stimulated AVS but high‑quality randomized multicenter evidence comparing sequential combined versus single‑strategy AVS is limited, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chongqing
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.