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

NCT04461535 | Completed

• 1 other identifier: ADOPA study
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

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

Conditions

Primary Aldosteronism

Keywords

primary aldosteronism; adrenal venous sampling; adrenocorticotropic hormone

Outcome Measures

Primary Outcomes (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.

  At 12 months of follow-up.

Secondary Outcomes (4)

• Compare the proportion of surgically treated patients who achieved complete clinical remission in the overall cohort between two groups

  At 12 months of follow-up.

• Daily defined doses (DDD) of antihypertensive agents (including MRA), blood pressure, proportion of patients reaching target blood pressure

  At 12 months of follow-up.

• Rate of bilaterally successful AVS

  At baseline.

• Adverse events

  At baseline and 12 month of follow-up.

Study Arms (2)

AVS with ACTH stimulation

EXPERIMENTAL

Patients divided into AVS with ACTH stimulation group need to undergo stimulation with a continuous cosyntropin infusion.

Drug: Adrenocorticotropic hormone

AVS without ACTH stimulation

NO INTERVENTION

Patients divided into AVS without ACTH stimulation group take the same procedure of AVS with a continuous saline infusion.

Interventions

Adrenocorticotropic hormone DRUG

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

AVS with ACTH stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chongqing Medical University: lead

Study Sites (1)

The First Affilated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

Related Publications (7)

• 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.

  PMID: 26934393 RESULT

• 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.

  PMID: 21828936 RESULT

• 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.

  PMID: 31176302 RESULT

• 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.

  PMID: 28420172 RESULT

• 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.

  PMID: 27325147 RESULT

• 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.

  PMID: 28576687 RESULT

• 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.

  PMID: 37870836 DERIVED

MeSH Terms

Conditions

Hyperaldosteronism

Interventions

Adrenocorticotropic Hormone

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Qifu Li, PhD

  the Chongqing Primary Aldosteronism Study (CONPASS) Group

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor.Qifu Li

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: July 8, 2020
• Study Start: July 8, 2020
• Primary Completion: February 20, 2023
• Study Completion: February 20, 2023
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)