Status:
COMPLETED
Corticotropin Stimulation in Adrenal Venous Sampling for Patients With Primary Aldosteronism(ADOPA)
Lead Sponsor:
Chongqing Medical University
Conditions:
Primary Aldosteronism
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
To compare the effect of different procedures of AVS(with or without ACTH stimulation) on the long-term outcomes of patients with PA
Detailed Description
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 A...
Eligibility Criteria
Inclusion
- Inclusion criteria: Patients who meet the following criterion can be included in this study.
- Aged between 18-70, male or female, with legal capacity
- PA diagnosis confirmed by at least one confirmatory test: positive PA screening (ARR≥ 2.0 ng·dl-1/IU·l-1) and at least one positive PA confirmatory test (PAC-post CCT ≥11 ng/dl, PAC-post SSIT≥8·0 ng/dl, or if confirmatory tests were in grey zone (i.e, PAC 8-11 ng/ml two hours after administration of 50 mg captopril or PAC 60-80 pg/ml after the infusion of 2L normal saline), PAC-post FST≥6·0 ng/dl);
- Exclusion criteria: Patients with one of the following conditions will be excluded in this study:
- refusal by the patient to undergo AVS or adrenalectomy;
- meeting the criteria for bypassing AVS \[i.e. younger than 35 years old, with typical aldosterone-producing adenomas characteristics (plasma aldosterone \>30ng/dl, serum potassium \<3·5mmol/l, CT indicated unilateral 1cm low-density adenoma) ;
- allergic to ACTH or contrast media;
- pregnant or lactating women;
- patients with a history of uncontrolled malignant tumor;
- complicated with Cushing's syndrome \[including subclinical Cushing: cortisol after 1mg dexamethasone suppression test (DST)\>138 nmol/l or cortisol after 1mg DST 50-138 nmol/l plus adrenocorticotrophic hormone (ACTH)\<10pg/ml;
- diagnosed with familial hyperaldosteronism;
- with imaging characteristics suggestive of pheochromocytoma or adrenal cortical carcinoma;
- patients unsuitable for surgery, such as those with heart failure (New York Heart Association (NYHA) class III or IV), severe anemia (Hemoglobin\<60g/L), stroke or acute coronary syndrome within 3 months, severe ascites and cirrhosis, estimated glomerulus filtration rate\<30ml/min/m2;
- with alcohol or drug abuse and active mental health disorders.
Exclusion
Key Trial Info
Start Date :
July 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2023
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT04461535
Start Date
July 8 2020
End Date
February 20 2023
Last Update
December 29 2023
Active Locations (1)
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1
The First Affilated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400016