Corticotropin Stimulation in Adrenal Venous Sampling for Patients With Primary Aldosteronism(ADOPA)

December 23, 2023 updated by: Qifu Li, Chongqing Medical University

Corticotropin Stimulation in Adrenal Venous Sampling for Patients With Primary Aldosteronism The ADOPA Randomized Clinical Trial

To compare the effect of different procedures of AVS(with or without ACTH stimulation) on the long-term outcomes of patients with PA

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

228

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • The First Affilated Hospital of Chongqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

1.Inclusion criteria: Patients who meet the following criterion can be included in this study.

  1. Aged between 18-70, male or female, with legal capacity
  2. 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);

2.Exclusion criteria: Patients with one of the following conditions will be excluded in this study:

  1. refusal by the patient to undergo AVS or adrenalectomy;
  2. 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) ;
  3. allergic to ACTH or contrast media;
  4. pregnant or lactating women;
  5. patients with a history of uncontrolled malignant tumor;
  6. 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;
  7. diagnosed with familial hyperaldosteronism;
  8. with imaging characteristics suggestive of pheochromocytoma or adrenal cortical carcinoma;
  9. 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;
  10. with alcohol or drug abuse and active mental health disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the proportion of surgically treated patients with complete biochemical remission in the overall cohort 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.
At 12 months of follow-up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: At baseline and 12 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, ect.
At baseline and 12 month of follow-up.
Compare the proportion of surgically treated patients who achieved complete clinical remission in the overall cohort between two groups
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.
At 12 months of follow-up.
Daily defined doses (DDD) of antihypertensive agents (including MRA), blood pressure, proportion of patients reaching target blood pressure
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 in each group irrespective of their treatment after 12 months of follow-up
At 12 months of follow-up.
Rate of bilaterally successful AVS
Time Frame: At baseline.
Calculate the rate of bilateral successful catheterization.Successful catheterization was defined as SI≥2 without ACTH stimulation or SI≥3 with ACTH stimulation.
At baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chongqing Medical University

Investigators

  • Study Chair: Qifu Li, PhD, the Chongqing Primary Aldosteronism Study (CONPASS) Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2020

Primary Completion (Actual)

February 20, 2023

Study Completion (Actual)

February 20, 2023

Study Registration Dates

First Submitted

June 22, 2020

First Submitted That Met QC Criteria

July 6, 2020

First Posted (Actual)

July 8, 2020

Study Record Updates

Last Update Posted (Actual)

December 29, 2023

Last Update Submitted That Met QC Criteria

December 23, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADOPA study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Aldosteronism

Clinical Trials on Adrenocorticotropic hormone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe