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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

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

Condition or disease Intervention/treatment Phase
Primary Aldosteronism Drug: Synacthen infusion during adrenal venous sampling Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Influence of Synacthen Infusion on the Results of Adrenal Venous Sampling in Patient With Primary Aldosteronism
Study Start Date : March 2011
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014


Arm Intervention/treatment
Experimental: Synacthen
Synacthen infusion during adrenal venous sampling
Drug: Synacthen infusion during adrenal venous sampling
Adrenal venous sampling during Synacthen infusion

No Intervention: Without Synacthen
Adrenal venous sampling without Synacthen



Primary Outcome Measures :
  1. 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. ]


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

Inclusion Criteria: Confirmed primary aldosteronism

Exclusion Criteria: Inability to undergo unilateral adrenalectomy


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02127840


Contacts
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Contact: Miroslav Solar, MD +420495834739 miroslav.solar@fnhk.cz
Contact: Jiri Ceral, MD +420495833249 ceral.jiri@fnhk.cz

Locations
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Czech Republic
University Hospital Hradec Kralove Recruiting
Hradec Kralove, Czech Republic, 50005
Contact: Miroslav Solar, MD    +420495834739    miroslav.solar@fnhk.cz   
Sponsors and Collaborators
Charles University, Czech Republic
University Hospital Hradec Kralove
Investigators
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Study Chair: Jiri Ceral, MD University Hospital Hradec Kralove

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Responsible Party: Miroslav Solar, Principal Investigator, Charles University, Czech Republic
ClinicalTrials.gov Identifier: NCT02127840     History of Changes
Other Study ID Numbers: PAAVS1143
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: May 1, 2014
Last Verified: April 2014
Keywords provided by Miroslav Solar, Charles University, Czech Republic:
primary aldosteronism
adrenal adenoma
arterial hypertension
Additional relevant MeSH terms:
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Hyperaldosteronism
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
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