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The Intra-Procedural Cortisol Assay During Adrenal Vein Sampling: Rationale and Design of a Randomized Study (I-Padua)

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Abstract

Introduction

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 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 hypothesis needs to be proven using a randomized prospective study approach.

Aim

We will therefore evaluate if an IRCA guiding adrenal vein sampling can increase the rate of selectivity and success of adrenal vein catheterization.

Methods

Consecutive patients with a biochemical diagnosis of PA and seeking surgical cure will be randomized to undergo AVS according to the usual practice with or without IRCA. The primary endpoint of the study will be the rate of bilaterally selective AVS studies, as defined by a value of the selective index >2.00 under baseline (unstimulated) conditions. With a total of 200 patients submitted to AVS, e.g. 100 patients in each arm, the study has 82% power to detect a 18% difference between arms at a two-sided α level =0.05.

Expected Results

Given this power the study should allow to conclusively determine if IRCA is useful or not for improving the success rate of AVS. From the clinical standpoint this will be a major accomplishment in the field of the subtyping of PA considering the current disastrous situation regarding the clinical use of AVS.

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Authors and Affiliations

  1. Department of Medicine-DIMED, Clinica dell’Ipertensione Arteriosa, University of Padova, Padua, Italy

    Maurizio Cesari, Giulio Ceolotto, Giacomo Rossitto, Giuseppe Maiolino, Teresa Maria Seccia & Gian Paolo Rossi

  2. Department of Medicine-DIMED, Hypertension Clinic, University Hospital, Via Giustiniani, 35128, Padua, Italy

    Gian Paolo Rossi

Authors
  1. Maurizio Cesari
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  2. Giulio Ceolotto
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  3. Giacomo Rossitto
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  4. Giuseppe Maiolino
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  5. Teresa Maria Seccia
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  6. Gian Paolo Rossi
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Corresponding author

Correspondence to Gian Paolo Rossi.

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Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

All procedures that will be performed in the study are in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The study will be started only after approval of the institutional Ethics Committee.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Cesari, M., Ceolotto, G., Rossitto, G. et al. The Intra-Procedural Cortisol Assay During Adrenal Vein Sampling: Rationale and Design of a Randomized Study (I-Padua). High Blood Press Cardiovasc Prev 24, 167–170 (2017). https://doi.org/10.1007/s40292-017-0192-5

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  • DOI: https://doi.org/10.1007/s40292-017-0192-5

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