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Compares treatment options for Primary Aldosteronism
Official title Sequential Combined Versus Single-Strategy Adrenal Venous Sampling for Primary Aldosteronism(SCOPE)
ClinicalTrials.gov ID: NCT07298954
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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.
You likely can't join if
- Patients for whom AVS can be bypassed: Typical BPA (normal serum potassium and plasma aldosterone concentration (PAC) \< 110 pg/mL, eligible for...
- 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).
See the full eligibility 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.
- 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...
- 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 ≥...
The study team makes the final eligibility decision.
Where it's taking place
- Chongqing, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chongqing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.