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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Complete biochemical remission
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 or above, male or female, with legal capacity;
- •Patients who diagnosed as primary aldosteronism and willing to surgery
Exclusion Criteria
- •Pregnant or lactating women
- •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
- •Having contraindications or refusal to undergo AVS or unilateral adrenalectomy, or allergy to ACTH;
- •PA combined with Cushing syndrome (including subclinical Cushing); or considering glucocorticoid-suppressible aldosteronism (GRA) or adrenocortical carcinoma;
Arms & Interventions
AVS after 1mg DST
Patients divided into AVS after 1mg DST group need to oral 1mg dexamethasone the night before AVS
Intervention: Dexamethasone 1 MG Oral Tablet (Drug)
AVS after placebo
Patients divided into AVS after placebo group need to oral placebo the night before AVS
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Complete biochemical remission
Time Frame: 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
Time Frame: 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 Outcomes
- Successful catheterization rate(procedure)
- Daily defined doses of antihypertensive agents(1 year)
- Adverse events(3 month)