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NCT02127840 Clinical Trial

Influence of Synacthen Infusion on the Results of Adrenal Venous Sampling in Patient With Primary Aldosteronism

Primary Aldosteronism Clinical Trial

— ISIRA  

Official title:
Influence of Synacthen Infusion on the Results of Adrenal Venous Sampling in Patient With Primary Aldosteronism

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02127840
Other study ID # PAAVS1143
Secondary ID
Status Recruiting
Phase Phase 4
First received April 25, 2014
Last updated April 28, 2014
Start date March 2011
Est. completion date December 2014

Study information
Verified date April 2014
Source Charles University, Czech Republic
Contact Miroslav Solar, MD
Phone +420495834739
Email miroslav.solar@fnhk.cz
Is FDA regulated No
Health authority Czech Republic: Ministry of Health
Study type Interventional

Clinical Trial Summary

The project is aimed to determine the value of synacthen infusion on the results of adrenal venous sampling in patients examined for primary aldosteronism

Description:

We aim to compare the results of adrenal venous sampling performed without and during synacthen infusion.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria: Confirmed primary aldosteronism

Exclusion Criteria: Inability to undergo unilateral adrenalectomy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• Synacthen infusion during adrenal venous sampling
Adrenal venous sampling during Synacthen infusion

Locations
Country Name City State
Czech Republic University Hospital Hradec Kralove Hradec Kralove

Sponsors (2)
Lead Sponsor Collaborator
Charles University, Czech Republic University Hospital Hradec Kralove

Country where clinical trial is conducted

Czech Republic, 

Outcome
Type Measure Description Time frame Safety issue
Primary To verify whether Synacthen infusion may influence the results of adrenal venous sampling in patients with primary aldosteronism End of clinical examination procedure, i.e. within 4 week after adrenal venous sampling is performed. No
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