AVS After 1mg DST to Determine Subtype in PA

Fudan University

Status: Completed

Conditions: Primary Aldosteronism

Treatments: Drug: Placebo; Drug: Dexamethasone 1 MG Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04709185

1mgDST AVS

Details and patient eligibility

About

To compare the effect of different procedures of AVS(after 1mg DST or not) in determining the subtypes and long-term outcomes of PA

Full description

All paticipants will be randomly divided into 1mg DST group(Intervention group,n=43) and placebo group(Control group,n=43) and to determining the subtypes and to compare the long-term outcomes of patients with PA.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 or above, male or female, with legal capacity;
2. Patients who diagnosed as primary aldosteronism and willing to surgery

Exclusion criteria

1. Pregnant or lactating women
2. Patients with a history of malignant tumors or complicated with severe heart disease, eGFR<30ml/min/1.73m2, severe anemia (Hb<60g/L), stroke or acute coronary syndrome within 3 months, severe liver disease
3. Having contraindications or refusal to undergo AVS or unilateral adrenalectomy, or allergy to ACTH;
4. PA combined with Cushing syndrome (including subclinical Cushing); or considering glucocorticoid-suppressible aldosteronism (GRA) or adrenocortical carcinoma;

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups, including a placebo group

AVS after 1mg DST

Experimental group

Description:

Patients divided into AVS after 1mg DST group need to oral 1mg dexamethasone the night before AVS

Treatment:

Drug: Dexamethasone 1 MG Oral Tablet

AVS after placebo

Placebo Comparator group

Description:

Patients divided into AVS after placebo group need to oral placebo the night before AVS

Treatment:

Drug: Placebo