AVS After 1mg DST to Determine Subtype in PA

Not Applicable

Completed

• Conditions: Primary Aldosteronism
• Interventions: Drug: Dexamethasone 1 MG Oral Tablet; Drug: Placebo

• Registration Number: NCT04709185
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Study Timeline

• Study Start: 2021-01-08
• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-01-13
• Study First Posted: 2021-01-14
• Primary Completion: 2022-10-30
• Study Completion: 2022-12-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-31
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AVS after 1mg DST	Dexamethasone 1 MG Oral Tablet	Patients divided into AVS after 1mg DST group need to oral 1mg dexamethasone the night before AVS
AVS after placebo	Placebo	Patients divided into AVS after placebo group need to oral placebo the night before AVS

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Adverse events	3 month	Including adrenal venous hemorrhage and related adrenal insufficiency, hypertensive urgencies, anaphylactic shock, venous thrombosis, pulmonary embolism.

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, China