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Rapid Cortisol Assay in Adrenal Vein Sampling (I-PADUA)

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ClinicalTrials.gov Identifier: NCT03449797
Recruitment Status : Not yet recruiting
First Posted : February 28, 2018
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
Gian Paolo Rossi, MD, FAHA, FACC, University Hospital Padova

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.


Condition or disease Intervention/treatment Phase
Primary Aldosteronism Due to Aldosterone Producing Adenoma Procedure: AVS performed with no intraprocedural rapid cortisol assay Procedure: AVS performed plus intraprocedural rapid cortisol assay Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: The Intra-Procedural Cortisol Assay During Adrenal Vein Sampling: Rationale andDesign of A Randomized Study (I-PADUA)
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2020


Arm Intervention/treatment
Sham Comparator: Group A
AAVS performed with no intraprocedural rapid cortisol assay
Procedure: AVS performed with no intraprocedural rapid cortisol assay
AVS performed plus intraprocedural rapid cortisol assay

Experimental: Group B
AVS performed plus intraprocedural rapid cortisol assay
Procedure: AVS performed plus intraprocedural rapid cortisol assay
Adrenal vein sampling performed according to usual clinical practice without intraprocedural rapid cortisol assay




Primary Outcome Measures :
  1. Assessment of selectivity of the sample [ Time Frame: two years ]
    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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: According to current guidelines consecutive patients with biochemical diagnosis of PA, who seek surgical cure of PA will be recruited for this study.These patients have a compelling indication to AVS before being referred or not for adrenalectomy.

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Exclusion Criteria: i) refusal of the center's to participate in the study; ii)refusal of the patientto undergo AVS and/or contraindications to the general anesthesia that is required for laparoscopic adrenalectomy; iii) cortisol -and aldosterone co-secreting adenoma.

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Publications of Results:

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Responsible Party: Gian Paolo Rossi, MD, FAHA, FACC, Professor of Medicine, University Hospital Padova
ClinicalTrials.gov Identifier: NCT03449797     History of Changes
Other Study ID Numbers: UHPadova
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gian Paolo Rossi, MD, FAHA, FACC, University Hospital Padova:
aldosterone
cortisol
adrenal vein sampling
primary aldosteronism
Additional relevant MeSH terms:
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Adenoma
Hyperaldosteronism
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents