NCT03449797

Brief Summary

Background: Adrenal vein sampling (AVS) is the gold standard test for the subtyping of primary aldosteronism (PA). This procedure is hampered by unsuccessful bilateral cannulation of adrenal veins, which can occur in up to two thirds of the cases depending on the cutoff of the selectivity index used. The rapid intra-procedural cortisol assay (IRCA) can increase the rate of bilateral success of AVS. This can be proven using a randomized prospective study design approach. Aim: We will therefore evaluate if an IRCA-guided AVS strategy can increase the rate of selectivity and thus the success rate of adrenal vein catheterization. Methods: Consecutive patients with a biochemical diagnosis of PA, seeking surgical cure, will be randomized to undergo AVS according to an IRCA-sham or an IRCA-guided procedure. Experimental and endpoint will be the rate of bilaterally selective AVS studies as defined by a selective index cutoff \> 2.00 value under baseline (unstimulated) conditions. With 100 patients submitted to AVS with a normal procedure and 100 patients undergoing AVS with IRCA, it has been estimated that the study has 82% power to detect a significant difference of 18% at a two-sided 0.05 significance level between arms. Expected results. Given this power we expect to the able to determine if IRCA is useful or not for improving the success rate of AVS. Given the current disastrous situation regarding the clinical use of AVS this will be a major accomplishment in the field of the subtyping of PA.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

March 9, 2018

Status Verified

March 1, 2018

Enrollment Period

1.3 years

First QC Date

February 22, 2018

Last Update Submit

March 8, 2018

Conditions

Primary Aldosteronism Due to Aldosterone Producing Adenoma

Keywords

aldosteronecortisoladrenal vein samplingprimary aldosteronism

Outcome Measures

Primary Outcomes (1)

  • Assessment of selectivity of the sample

    Selectivity will be determined on both side by using a value of the selectivity index \> 2.00 as defined in an Expert Consensus Statement of AVS. Selectivity is the ratio between plasma cortisol concentration in each adrenal vein and in the infrarenal inferior vena cava blood.

    two years

Study Arms (2)

Group A

SHAM COMPARATOR

AAVS performed with no intraprocedural rapid cortisol assay

Procedure: AVS performed with no intraprocedural rapid cortisol assay

Group B

EXPERIMENTAL

AVS performed plus intraprocedural rapid cortisol assay

Procedure: AVS performed plus intraprocedural rapid cortisol assay

Interventions

AVS performed with no intraprocedural rapid cortisol assayPROCEDURE

AVS performed plus intraprocedural rapid cortisol assay

Group A
AVS performed plus intraprocedural rapid cortisol assayPROCEDURE

Adrenal vein sampling performed according to usual clinical practice without intraprocedural rapid cortisol assay

Group B

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (16)

  • Rossi GP, Bernini G, Caliumi C, Desideri G, Fabris B, Ferri C, Ganzaroli C, Giacchetti G, Letizia C, Maccario M, Mallamaci F, Mannelli M, Mattarello MJ, Moretti A, Palumbo G, Parenti G, Porteri E, Semplicini A, Rizzoni D, Rossi E, Boscaro M, Pessina AC, Mantero F; PAPY Study Investigators. A prospective study of the prevalence of primary aldosteronism in 1,125 hypertensive patients. J Am Coll Cardiol. 2006 Dec 5;48(11):2293-300. doi: 10.1016/j.jacc.2006.07.059. Epub 2006 Nov 13.

    PMID: 17161262RESULT

  • Douma S, Petidis K, Doumas M, Papaefthimiou P, Triantafyllou A, Kartali N, Papadopoulos N, Vogiatzis K, Zamboulis C. Prevalence of primary hyperaldosteronism in resistant hypertension: a retrospective observational study. Lancet. 2008 Jun 7;371(9628):1921-6. doi: 10.1016/S0140-6736(08)60834-X.

    PMID: 18539224RESULT

  • Olivieri O, Ciacciarelli A, Signorelli D, Pizzolo F, Guarini P, Pavan C, Corgnati A, Falcone S, Corrocher R, Micchi A, Cressoni C, Blengio G. Aldosterone to Renin ratio in a primary care setting: the Bussolengo study. J Clin Endocrinol Metab. 2004 Sep;89(9):4221-6. doi: 10.1210/jc.2003-032179.

    PMID: 15356010RESULT

  • Rossi GP, Cesari M, Cuspidi C, Maiolino G, Cicala MV, Bisogni V, Mantero F, Pessina AC. Long-term control of arterial hypertension and regression of left ventricular hypertrophy with treatment of primary aldosteronism. Hypertension. 2013 Jul;62(1):62-9. doi: 10.1161/HYPERTENSIONAHA.113.01316. Epub 2013 May 6.

    PMID: 23648698RESULT

  • Rossitto G, Miotto D, Battistel M, Barbiero G, Maiolino G, Bisogni V, Sanga V, Rossi GP. Metoclopramide unmasks potentially misleading contralateral suppression in patients undergoing adrenal vein sampling for primary aldosteronism. J Hypertens. 2016 Nov;34(11):2258-65. doi: 10.1097/HJH.0000000000001082.

    PMID: 27512976RESULT

  • Weinberger MH, Grim CE, Hollifield JW, Kem DC, Ganguly A, Kramer NJ, Yune HY, Wellman H, Donohue JP. Primary aldosteronism: diagnosis, localization, and treatment. Ann Intern Med. 1979 Mar;90(3):386-95. doi: 10.7326/0003-4819-90-3-386.

    PMID: 218482RESULT

  • Young WF Jr, Stanson AW, Grant CS, Thompson GB, van Heerden JA. Primary aldosteronism: adrenal venous sampling. Surgery. 1996 Dec;120(6):913-9; discussion 919-20.

    PMID: 8957473RESULT

  • Young WF, Stanson AW, Thompson GB, Grant CS, Farley DR, van Heerden JA. Role for adrenal venous sampling in primary aldosteronism. Surgery. 2004 Dec;136(6):1227-35. doi: 10.1016/j.surg.2004.06.051.

    PMID: 15657580RESULT

  • Rossi GP, Auchus RJ, Brown M, Lenders JW, Naruse M, Plouin PF, Satoh F, Young WF Jr. An expert consensus statement on use of adrenal vein sampling for the subtyping of primary aldosteronism. Hypertension. 2014 Jan;63(1):151-60. doi: 10.1161/HYPERTENSIONAHA.113.02097. Epub 2013 Nov 11.

    PMID: 24218436RESULT

  • Seccia TM, Miotto D, De Toni R, Pitter G, Mantero F, Pessina AC, Rossi GP. Adrenocorticotropic hormone stimulation during adrenal vein sampling for identifying surgically curable subtypes of primary aldosteronism: comparison of 3 different protocols. Hypertension. 2009 May;53(5):761-6. doi: 10.1161/HYPERTENSIONAHA.108.128553. Epub 2009 Apr 6.

    PMID: 19349554RESULT

  • Lenders JW, Duh QY, Eisenhofer G, Gimenez-Roqueplo AP, Grebe SK, Murad MH, Naruse M, Pacak K, Young WF Jr; Endocrine Society. Pheochromocytoma and paraganglioma: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2014 Jun;99(6):1915-42. doi: 10.1210/jc.2014-1498.

    PMID: 24893135RESULT

  • Woods JJ, Sampson ML, Ruddel ME, Remaley AT. Rapid intraoperative cortisol assay: design and utility for localizing adrenal tumors by venous sampling. Clin Biochem. 2000 Aug;33(6):501-3. doi: 10.1016/s0009-9120(00)00141-7. No abstract available.

    PMID: 11074243RESULT

  • Mengozzi G, Rossato D, Bertello C, Garrone C, Milan A, Pagni R, Veglio F, Mulatero P. Rapid cortisol assay during adrenal vein sampling in patients with primary aldosteronism. Clin Chem. 2007 Nov;53(11):1968-71. doi: 10.1373/clinchem.2007.092080. Epub 2007 Sep 27.

    PMID: 17901112RESULT

  • Yoneda T, Karashima S, Kometani M, Usukura M, Demura M, Sanada J, Minami T, Koda W, Gabata T, Matsui O, Idegami K, Takamura Y, Tamiya E, Oe M, Nakai M, Mori S, Terayama N, Matsuda Y, Kamemura K, Fujii S, Seta T, Sawamura T, Okuda R, Takeda Y, Hayashi K, Yamagishi M, Takeda Y. Impact of New Quick Gold Nanoparticle-Based Cortisol Assay During Adrenal Vein Sampling for Primary Aldosteronism. J Clin Endocrinol Metab. 2016 Jun;101(6):2554-61. doi: 10.1210/jc.2016-1011. Epub 2016 Mar 24.

    PMID: 27011114RESULT

  • 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: 26934393RESULT

  • Rossi GP, Ganzaroli C, Miotto D, De Toni R, Palumbo G, Feltrin GP, Mantero F, Pessina AC. Dynamic testing with high-dose adrenocorticotrophic hormone does not improve lateralization of aldosterone oversecretion in primary aldosteronism patients. J Hypertens. 2006 Feb;24(2):371-9. doi: 10.1097/01.hjh.0000202818.10459.96.

    PMID: 16508586RESULT

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

February 22, 2018

First Posted

February 28, 2018

Study Start

April 1, 2018

Primary Completion

July 31, 2019

Study Completion

July 31, 2020

Last Updated

March 9, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share