AVS After 1mg DST to Determine Subtype in PA

Adrenal Venous Sampling Under 1 mg Overnight Dexamethasone Suppression Test to Determine Subtype in Primary Aldosteronism，a Single Center, Randomized, Double Blended, Placebo Controlled Clinical Trail

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04709185

Enrollment

110

Registered

2021-01-14

Start date

2021-01-08

Completion date

2022-12-30

Last updated

2023-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Aldosteronism

Keywords

primary aldosteronism, adrenal venous sampling

Brief summary

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

Detailed 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.

Interventions

DRUGDexamethasone 1 MG Oral Tablet

oral 1 mg dexamethasone at 23:00-24:00 the night before AVS

DRUGPlacebo

oral placebo at 23:00-24:00 the night before AVS

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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;

Design outcomes

Primary

Measure	Time frame	Description
Complete biochemical remission	1year	Compare the rate of complete biochemical remission between two groups. 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.
Complete clinical remission	1 year	Compare the rate of complete clinical remission between two groups. 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
Adverse events	3 month	Including adrenal venous hemorrhage and related adrenal insufficiency, hypertensive urgencies, anaphylactic shock, venous thrombosis, pulmonary embolism.
Daily defined doses of antihypertensive agents	1 year	The daily defined doses of antihypertensive agents of patients' blood pressure well controlled
Successful catheterization rate	procedure	Calculate the successful rate of catheterization. Successful catheterization was defined as SI≥2 without ACTH stimulation or SI≥3 with ACTH stimulation.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026