NCT02127840

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 1, 2014

Status Verified

April 1, 2014

Enrollment Period

3.8 years

First QC Date

April 25, 2014

Last Update Submit

April 28, 2014

Conditions

Primary Aldosteronism

Keywords

primary aldosteronismadrenal adenomaarterial hypertension

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Synacthen

EXPERIMENTAL

Synacthen infusion during adrenal venous sampling

Drug: Synacthen infusion during adrenal venous sampling

Without Synacthen

NO INTERVENTION

Adrenal venous sampling without Synacthen

Interventions

Synacthen infusion during adrenal venous samplingDRUG

Adrenal venous sampling during Synacthen infusion

Synacthen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

RECRUITING

MeSH Terms

Conditions

HyperaldosteronismACTH Syndrome, EctopicHypertension

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System DiseasesParaneoplastic Endocrine SyndromesParaneoplastic SyndromesNeoplasmsVascular DiseasesCardiovascular Diseases

Study Officials

  • Jiri Ceral, MD

    University Hospital Hradec Kralove

    STUDY CHAIR

Central Study Contacts

Miroslav Solar, MD

CONTACT

+420495834739miroslav.solar@fnhk.cz

Jiri Ceral, MD

CONTACT

+420495833249ceral.jiri@fnhk.cz

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 25, 2014

First Posted

May 1, 2014

Study Start

March 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

May 1, 2014

Record last verified: 2014-04

Locations

CZ(1)