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

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ClinicalTrials.gov Identifier: NCT02127840
Recruitment Status : Unknown
Verified April 2014 by Miroslav Solar, Charles University, Czech Republic.
Recruitment status was:  Recruiting
First Posted : May 1, 2014
Last Update Posted : May 1, 2014
Sponsor:
Collaborator:
University Hospital Hradec Kralove
Information provided by (Responsible Party):
Miroslav Solar, Charles University, Czech Republic

Tracking Information
First Submitted Date  ICMJE April 25, 2014
First Posted Date  ICMJE May 1, 2014
Last Update Posted Date May 1, 2014
Study Start Date  ICMJE March 2011
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2014)
To verify whether Synacthen infusion may influence the results of adrenal venous sampling in patients with primary aldosteronism [ Time Frame: End of clinical examination procedure, i.e. within 4 week after adrenal venous sampling is performed. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influence of Synacthen Infusion on the Results of Adrenal Venous Sampling in Patient With Primary Aldosteronism
Official Title  ICMJE Influence of Synacthen Infusion on the Results of Adrenal Venous Sampling in Patient With Primary Aldosteronism
Brief 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
Detailed Description We aim to compare the results of adrenal venous sampling performed without and during synacthen infusion.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Primary Aldosteronism
Intervention  ICMJE Drug: Synacthen infusion during adrenal venous sampling
Adrenal venous sampling during Synacthen infusion
Study Arms  ICMJE
  • Experimental: Synacthen
    Synacthen infusion during adrenal venous sampling
    Intervention: Drug: Synacthen infusion during adrenal venous sampling
  • No Intervention: Without Synacthen
    Adrenal venous sampling without Synacthen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 28, 2014)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2014
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: Confirmed primary aldosteronism

Exclusion Criteria: Inability to undergo unilateral adrenalectomy

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02127840
Other Study ID Numbers  ICMJE PAAVS1143
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Miroslav Solar, Charles University, Czech Republic
Study Sponsor  ICMJE Charles University, Czech Republic
Collaborators  ICMJE University Hospital Hradec Kralove
Investigators  ICMJE
Study Chair: Jiri Ceral, MD University Hospital Hradec Kralove
PRS Account Charles University, Czech Republic
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP