Clinical trial NCT04378387: Ipsilateral and Contralateral Index for the Interpretation of Adrenal Vein Sampling (AVS) in Primary Aldosteronism
Official title: Usefulness of the Ipsilateral and Contralateral Index for the Interpretation of Adrenal Vein Sampling (AVS) in the Subtype Diagnosis of Primary Aldosteronism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Aldosteronism
Primary Aldosteronism Due to Aldosterone Producing Adenoma
Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
Keywords: Primary Aldosteronism
Primary Aldosteronism Due to Aldosterone Producing Adenoma
Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
Adrenal Vein Sampling
Renin-Angiotensin-Aldosterone System
Blood Pressure
Lateralization Index
Ipsilateral Index
Contralateral Index
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients followed by our center with age over 18 years old and a diagnosis of primary aldosteronism, who underwent a successful (i.e. with successful catheterization of both adrenal veins) unstimulated adrenal vein sampling between January 2005 and April 2020.

Brief summary: Adrenal vein sampling (AVS) is currently considered the gold standard for subtype diagnosis of primary aldosteronism (PA). However, the percentage of unsuitable procedures due to the unsuccessful cannulation of one of the two adrenal veins is still considerable, and there is no general consensus on the criteria that should be used for the interpretation of the results of an AVS study in these specific cases.

Detailed description: The differentiation between subtypes of primary aldosteronism (PA) is fundamental to refer each patient to the most appropriate therapeutic approach (surgical in case of unilateral disease and medical in case of bilateral disease). Adrenal vein sampling (AVS) is currently considered the gold standard for such differentiation between subtypes.

However, despite significant progress in optimizing the AVS procedure, the percentage of unsuitable procedures due to the unsuccessful cannulation of one of the two adrenal veins is still considerable, especially in less experienced centers.

It would therefore be important to identify criteria for the interpretation of the results of a suboptimal AVS study (i.e. with sampling of only one of the two adrenal veins). This problem has recently been addressed by some groups; however, there is still no general consensus on these criteria and all existing studies must be considered exploratory in this field.

In this study, therefore, all patients with PA followed by our center and who underwent a successful (i.e. with correct cannulation and sampling from both adrenal veins) unstimulated (i.e. without cosyntropin stimulation) AVS procedure will be retrospectively evaluated.

If a reliable unilateral index could be identified for subtype diagnosis, this tool could be used for the interpretation of suboptimal AVS data, thus preventing a certain percentage of patients from the necessity to repeat the procedure and allowing to refer each one, also on the basis of an incomplete dataset, to the most appropriate therapeutic approach.

Eligibility criteria: Inclusion Criteria:

* Confirmed Diagnosis of Primary Aldosteronism
* Execution of Adrenal Vein Sampling (AVS) for Subtype Diagnosis

Exclusion Criteria:

* Execution of AVS in stimulated condition (i.e. with cosyntropin stimulation)
* Inability to achieve successful catheterization of one or both adrenal veins during AVS (as established by adrenal/peripheral vein cortisol ratio)

Primary outcomes:
measure: Monolateral index for each adrenal gland in each patient
timeFrame: At AVS procedure
measure: Aldosterone/cortisol index for each adrenal gland in each patient
timeFrame: At AVS procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Torino
country: Italy
facility: Division of Endocrinology, Diabetology and Metabolism; University of Turin
state: Piemonte
Study officials:
affiliation: Endocrinology, Diabetology and Metabolism; University of Turin
name: Mauro Maccario, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Endocrinology, Diabetology and Metabolism; University of Turin
name: Ezio Ghigo, MD
role: STUDY_CHAIR
References:
citation: 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.
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citation: Fujii Y, Umakoshi H, Wada N, Ichijo T, Kamemura K, Matsuda Y, Kai T, Fukuoka T, Sakamoto R, Ogo A, Suzuki T, Nanba K, Tsuiki M, Naruse M; WAVES-J Study Group. Subtype prediction of primary aldosteronism by combining aldosterone concentrations in the left adrenal vein and inferior vena cava: a multicenter collaborative study on adrenal venous sampling. J Hum Hypertens. 2017 Dec;32(1):12-19. doi: 10.1038/s41371-017-0015-0. Epub 2017 Nov 24.
citation: Lee BC, Chang CC; TAIPAI Study Group. Regarding "Diagnostic utility of data from adrenal venous sampling for primary aldosteronism despite failed cannulation of the right adrenal vein". Surgery. 2016 May;159(5):1478-9. doi: 10.1016/j.surg.2015.10.033. Epub 2015 Dec 17. No abstract available.
citation: Strajina V, Al-Hilli Z, Andrews JC, Bancos I, Thompson GB, Farley DR, Lyden ML, Dy BM, Young WF, McKenzie TJ. Primary aldosteronism: making sense of partial data sets from failed adrenal venous sampling-suppression of adrenal aldosterone production can be used in clinical decision making. Surgery. 2018 Apr;163(4):801-806. doi: 10.1016/j.surg.2017.10.012. Epub 2017 Nov 22.
citation: Wang TS, Kline G, Yen TW, Yin Z, Liu Y, Rilling W, So B, Findling JW, Evans DB, Pasieka JL. A Multi-institutional Comparison of Adrenal Venous Sampling in Patients with Primary Aldosteronism: Caution Advised if Successful Bilateral Adrenal Vein Sampling is Not Achieved. World J Surg. 2018 Feb;42(2):466-472. doi: 10.1007/s00268-017-4327-6.