Primary Aldosteronism
Conditions
Keywords
Primary Aldosteronism, Adrenal venous sampling, sequential combined AVS, non-ACTH-stimulated, ACTH-stimulated AVS, complete biochemical remission rate
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.
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.
Interventions
DIAGNOSTIC_TESTsequential combined AVS
non-ACTH-stimulated followed by ACTH-stimulated AVS
Sponsors
First Affiliated Hospital of Kunming Medical University
The First Affiliated Hospital of Nanchang University
The People's Hospital of Chuxiong Yi Autonomous Prefecture
Shumin Yang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of complete biochemical remission | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of complete biochemical response rate | 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. |
| The proportion of complete clinical response rate | 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. |
| Comparison of adverse events | 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. |
| The proportion of complete clinical remission | 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. |
| In surgical population, the proportion of complete clinical remission | 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. |
| In medication population, the proportion of complete biochemical response rate | 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. |
| In medication population, the proportion of complete clinical response rate | 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. |
| In surgical population, the proportion of complete biochemical remission | 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. |
Countries
China
Contacts
Primary ContactShumin Yang
Outcome results
None listed