An interventional study of Dexamethasone 1 MG Oral Tablet and Placebo in Primary Aldosteronism, sponsored by Shanghai Zhongshan Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-01.
Sponsored by Shanghai Zhongshan Hospital · Not applicable, Interventional, and Diagnostic
To compare the effect of different procedures of AVS(after 1mg DST or not) in determining the subtypes and long-term outcomes of PA
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.
196 studies on the registry are indexed under Hyperaldosteronism; 88 are open to participants now.
This study's enrollment of 110 is above the median of 60 across 93 interventional studies indexed under Hyperaldosteronism.
Browse Hyperaldosteronism studies →Shanghai Zhongshan Hospital is the lead sponsor of 648 studies on the registry; 289 are open to participants now.
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Exclusion Criteria:
Patients divided into AVS after 1mg DST group need to oral 1mg dexamethasone the night before AVS
Drug: Dexamethasone 1 MG Oral Tablet
Patients divided into AVS after placebo group need to oral placebo the night before AVS
Drug: Placebo
oral 1 mg dexamethasone at 23:00-24:00 the night before AVS
oral placebo at 23:00-24:00 the night before AVS
Complete biochemical remission
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.
Time frame: 1year
Complete clinical remission
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.
Time frame: 1 year
Daily defined doses of antihypertensive agents
The daily defined doses of antihypertensive agents of patients' blood pressure well controlled
Time frame: 1 year
Successful catheterization rate
Calculate the successful rate of catheterization. Successful catheterization was defined as SI≥2 without ACTH stimulation or SI≥3 with ACTH stimulation.
Time frame: procedure
Adverse events
Including adrenal venous hemorrhage and related adrenal insufficiency, hypertensive urgencies, anaphylactic shock, venous thrombosis, pulmonary embolism.
Time frame: 3 month
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2021 to primary completion in Oct 2022, 21 months.
Of 36 interventional studies with no phase under Hyperaldosteronism, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's 21 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexamethasone