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Primary AldosteronismNCT04461535

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

A study testing Adrenocorticotropic hormone in people with Primary Aldosteronism, run by Chongqing Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Primary Aldosteronism
What is being tested?
Adrenocorticotropic hormone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
228 participants
Where
1 siteChina
Study dates
8 Jul 2020to 20 Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affilated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

Other trials in China

About this study

Official title: 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

Read the 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.

Being tested
Adrenocorticotropic hormone
Keywords
primary aldosteronism, adrenal venous sampling, adrenocorticotropic hormone
Medical subject headings
Hyperaldosteronism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adrenocorticotropic hormoneDrug

    Also called ACTH

    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.

Study groups in NCT04461535
Study groupRoleWhat they receive
AVS with ACTH stimulationExperimentalPatients divided into AVS with ACTH stimulation group need to undergo stimulation with a continuous cosyntropin infusion.
Receives: Drug: Adrenocorticotropic hormone
AVS without ACTH stimulationNo interventionPatients divided into AVS without ACTH stimulation group take the same procedure of AVS with a continuous saline infusion.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At 12 months of follow-up.

Secondary outcomes (4)

  1. 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.

    Measured: At 12 months of follow-up.

  2. 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

    Measured: At 12 months of follow-up.

  3. 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.

    Measured: At baseline.

  4. 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.

    Measured: At baseline and 12 month of follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2020
  2. Study start8 Jul 2020
  3. Primary completion20 Feb 2023
  4. Study completion20 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
228 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04461535
Sponsor's protocol ID
ADOPA study
Status last verified
Dec 2023
First submitted
22 Jun 2020
Last updated
29 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Funder JW, Carey RM, Mantero F, Murad MH, Reincke M, Shibata H, Stowasser M, Young WF Jr. The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016 May;101(5):1889-916. doi: 10.1210/jc.2015-4061. Epub 2016 Mar 2.

    PubMed 26934393

  • Nishikawa T, Omura M, Satoh F, Shibata H, Takahashi K, Tamura N, Tanabe A; Task Force Committee on Primary Aldosteronism, The Japan Endocrine Society. Guidelines for the diagnosis and treatment of primary aldosteronism--the Japan Endocrine Society 2009. Endocr J. 2011;58(9):711-21. doi: 10.1507/endocrj.ej11-0133. Epub 2011 Aug 9.

    PubMed 21828936

  • Deinum J, Groenewoud H, van der Wilt GJ, Lenzini L, Rossi GP. Adrenal venous sampling: cosyntropin stimulation or not? Eur J Endocrinol. 2019 Sep;181(3):D15-D26. doi: 10.1530/EJE-18-0844.

    PubMed 31176302

  • Buffolo F, Monticone S, Williams TA, Rossato D, Burrello J, Tetti M, Veglio F, Mulatero P. Subtype Diagnosis of Primary Aldosteronism: Is Adrenal Vein Sampling Always Necessary? Int J Mol Sci. 2017 Apr 17;18(4):848. doi: 10.3390/ijms18040848.

    PubMed 28420172

  • Dekkers T, Prejbisz A, Kool LJS, Groenewoud HJMM, Velema M, Spiering W, Kolodziejczyk-Kruk S, Arntz M, Kadziela J, Langenhuijsen JF, Kerstens MN, van den Meiracker AH, van den Born BJ, Sweep FCGJ, Hermus ARMM, Januszewicz A, Ligthart-Naber AF, Makai P, van der Wilt GJ, Lenders JWM, Deinum J; SPARTACUS Investigators. Adrenal vein sampling versus CT scan to determine treatment in primary aldosteronism: an outcome-based randomised diagnostic trial. Lancet Diabetes Endocrinol. 2016 Sep;4(9):739-746. doi: 10.1016/S2213-8587(16)30100-0. Epub 2016 Jun 17.

    PubMed 27325147

  • Williams TA, Lenders JWM, Mulatero P, Burrello J, Rottenkolber M, Adolf C, Satoh F, Amar L, Quinkler M, Deinum J, Beuschlein F, Kitamoto KK, Pham U, Morimoto R, Umakoshi H, Prejbisz A, Kocjan T, Naruse M, Stowasser M, Nishikawa T, Young WF Jr, Gomez-Sanchez CE, Funder JW, Reincke M; Primary Aldosteronism Surgery Outcome (PASO) investigators. Outcomes after adrenalectomy for unilateral primary aldosteronism: an international consensus on outcome measures and analysis of remission rates in an international cohort. Lancet Diabetes Endocrinol. 2017 Sep;5(9):689-699. doi: 10.1016/S2213-8587(17)30135-3. Epub 2017 May 30.

    PubMed 28576687

  • Yang S, Du Z, Zhang X, Zhen Q, Shu X, Yang J, Song Y, Yang Y, Li Q, Hu J; Chongqing Primary Aldosteronism Study (CONPASS) Group. Corticotropin Stimulation in Adrenal Venous Sampling for Patients With Primary Aldosteronism: The ADOPA Randomized Clinical Trial. JAMA Netw Open. 2023 Oct 2;6(10):e2338209. doi: 10.1001/jamanetworkopen.2023.38209.

    PubMed 37870836

Questions about this trial

What is this clinical trial studying?

A study testing Adrenocorticotropic hormone in people with Primary Aldosteronism, run by Chongqing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04461535, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.

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