Compare Outcomes of AVS With or Without ACTH Stimulation
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|ClinicalTrials.gov Identifier: NCT04461535|
Recruitment Status : Recruiting
First Posted : July 8, 2020
Last Update Posted : May 4, 2021
|Condition or disease||Intervention/treatment||Phase|
|Primary Aldosteronism||Drug: Adrenocorticotropic hormone||Not Applicable|
This is a prospective, randomized, double-blinded study involving 200 patients with primary aldosteronism(PA) who completed AVS.
All paticipants will be randomized into ACTH-stimulated group(Intervention group,n=100) and ACTH-unstimulated group(Control group,n=100) and to compare the long-term outcomes of patients with PA.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Adrenal Venous Sampling With or Without Adrenocorticotropic Hormone Stimulation to Determine Outcomes in Primary Aldosteronism: an Outcome-based Randomized Study|
|Actual Study Start Date :||May 1, 2020|
|Estimated Primary Completion Date :||May 1, 2023|
|Estimated Study Completion Date :||May 1, 2023|
Experimental: AVS with ACTH stimulation
Patients divided into AVS with ACTH stimulation group need to undergo stimulation with a continuous cosyntropin infusion.
Drug: Adrenocorticotropic hormone
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.
Other Name: ACTH
No Intervention: AVS without ACTH stimulation
Patients divided into AVS without ACTH stimulation group take the same procedure of AVS with a continuous saline infusion.
- Compare the rate of complete biochemical remission between two groups [ Time Frame: At 12 months of follow-up. ]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: At 12 months of follow-up. ]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.
- Daily defined doses (DDD) of antihypertensive agents [ Time Frame: At 12 months of follow-up. ]When patients' blood pressure get well controlled(SBP<140mmHg and DBP<90mmHg), calculate the daily defined doses (DDD) of antihypertensive agents.
- Successful catheterization. [ Time Frame: At baseline ]Calculate the rate of successful catheterization.Successful catheterization was defined as SI≥2 without ACTH stimulation or SI≥3 with ACTH stimulation.
- Adverse events [ Time Frame: At baseline and 1 month of follow-up. ]Record the occurrence of adverse events, including adrenal venous hemorrhage and related adrenal insufficiency, hypertensive urgencies, anaphylactic shock, venous thrombosis, pulmonary embolism.
- The health-related quality of life [ Time Frame: At baseline and 12 months of follow-up. ]Compare the quality of life score between two groups,using EuroQol-5 Dimension Visual Analogue Scale (VAS) score.The minimum and maximum values are 0 and 100,respectively. And higher scores mean a better outcome.
- bilateral adosterone inhibiton (BAS) in AVS [ Time Frame: At baseline ]calculate the BAS rate in AVS
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04461535
|Contact: Qifu Li, PhD||+86 firstname.lastname@example.org|
|Study Chair:||Qifu Li, PhD||the Chongqing Primary Aldosteronism Study (CONPASS) Group|