An interventional study of Adrenocorticotropic hormone in Primary Aldosteronism, sponsored by Chongqing Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-12-29.
Sponsored by Chongqing Medical University · Not applicable, Interventional, and Diagnostic
To compare the effect of different procedures of AVS(with or without ACTH stimulation) on the long-term outcomes of patients with PA
This is a prospective and randomized study involving patients with primary aldosteronism(PA) who completed AVS.
All paticipants will be randomized into ACTH-stimulated group(Intervention group) and ACTH-unstimulated group(Control group) Cannulation was considered successful when the selectivity index (SI), namely plasma cortisol concentration (PCC) in adrenal vein/PCC in IVC≥3 with ACTH stimulation or SI≥2 without ACTH stimulation. The ratio of PAC: PCC on the side with the higher ratio over the contralateral PAC: PCC ratio is defined as the lateralization index (LI). Lateralization of aldosterone excess was defined as LI≥4 irrespective of ACTH use. Patients with LI between 2 and 4 together with contralateral suppression (PAC/PCC of non-dominant side \< PAC/PCC of IVC) or CT showing a typical adenoma on the dominant side were also considered to have lateralized disease. Patients with LI \< 2 or LI 2-4 without meeting the above criteria were diagnosed as BPA.
In case of technical AVS failure or bilateral PAC/PCC in adrenal venous blood lower than peripheral blood, if the patient meets one of the following criteria, adrenalectomy was recommended: 1) unilateral nodule on CT (≥ 1 cm), no observable nodules or hyperplasia on contralateral adrenal, and PAC ≥ 20 ng/dl, PRC \< 5 μIU/ml, K ≤ 3.5mmol/l; 2) unilateral nodule on CT (≥ 1 cm), no observable nodules or hyperplasia on contralateral adrenal, and the contralateral index≤0.5 in AVS.
Surgical intervention is recommended for unilateral PA (UPA) whereas bilateral PA (BPA) is typically treated with oral mineralocorticoid receptor antagonists such as spironolactone. The aim is to compare the long-term outcomes of patients with PA.
To evaluate whether the treatment decision (surgical or medical treatment) based on different AVS procedures (with or without ACTH stimulation) would lead to different outcomes in patients with PA.
193 studies on the registry are indexed under Hyperaldosteronism; 89 are open to participants now.
This study's enrollment of 228 is above the median of 60 across 91 interventional studies indexed under Hyperaldosteronism.
Browse Hyperaldosteronism studies →Chongqing Medical University is the lead sponsor of 75 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
1.Inclusion criteria: Patients who meet the following criterion can be included in this study.
2.Exclusion criteria: Patients with one of the following conditions will be excluded in this study:
Patients divided into AVS with ACTH stimulation group need to undergo stimulation with a continuous cosyntropin infusion.
Drug: Adrenocorticotropic hormone
Patients divided into AVS without ACTH stimulation group take the same procedure of AVS with a continuous saline infusion.
Patients divided into Intervention group need to undergo stimulation with a continuous cosyntropin infusion (50 μg/h started 30 minutes before sampling during AVS). Right and left adrenal venous blood and corresponding peripheral venous blood should be sampled sequentially.
Also known as: ACTH
Compare the proportion of surgically treated patients with complete biochemical remission in the overall cohort 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: At 12 months of follow-up.
Compare the proportion of surgically treated patients who achieved complete clinical remission in the overall cohort between two groups
The proportion of complete clinical remission according to PASO consensus criteria.Clinical outcomes were determined by the blood pressure response to treatment and the number and dosage of antihypertensive medications.
Time frame: At 12 months of follow-up.
Daily defined doses (DDD) of antihypertensive agents (including MRA), blood pressure, proportion of patients reaching target blood pressure
Daily defined doses (DDD) of antihypertensive agents (including MRA), blood pressure, proportion of patients reaching target blood pressure in each group irrespective of their treatment after 12 months of follow-up
Time frame: At 12 months of follow-up.
Rate of bilaterally successful AVS
Calculate the rate of bilateral successful catheterization.Successful catheterization was defined as SI≥2 without ACTH stimulation or SI≥3 with ACTH stimulation.
Time frame: At baseline.
Adverse events
Record the occurrence of adverse events, including adrenal venous hemorrhage and related adrenal insufficiency, hypertensive urgencies, anaphylactic shock, venous thrombosis, pulmonary embolism, ect.
Time frame: At baseline and 12 month of follow-up.
Plan to share: No
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Chongqing Medical University