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NCT03449797: I-PADUA
Rapid Cortisol Assay in Adrenal Vein Sampling
NA trial testing AVS performed with no intraprocedural rapid cortisol assay in Primary Aldosteronism Due to Aldosterone Producing Adenoma in 200 participants. Status unknown.
31 July 2019
Quick facts
| Lead sponsor | University Hospital Padova |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | diagnostic |
| Enrollment | 200 |
| Start date | 1 April 2018 |
| Primary completion | 31 July 2019 |
| Estimated completion | 31 July 2020 |
Drugs / interventions tested
- AVS performed with no intraprocedural rapid cortisol assay
- AVS performed plus intraprocedural rapid cortisol assay
Conditions studied
- Primary Aldosteronism Due to Aldosterone Producing Adenoma — all drugs for Primary Aldosteronism Due to Aldosterone Producing Adenoma →
Sponsor
University Hospital Padova
Who can join
Adults 18 to 75, any sex, with Primary Aldosteronism Due to Aldosterone Producing Adenoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Other University Hospital Padova trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03449797 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital Padova
- Last refreshed: 9 March 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03449797.
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