Plasma Metanephrines in Patients With Cyanotic and Acyano... | NCT04891081

Studies
Plasma Metanephrines in Patients With Cyanotic and Acyanotic Congenital Heart Disease

NCT04891081

Sponsor

University Medical Centre Ljubljana

Status

Unknown status

Last Update Posted

May 18, 2021Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Acyanotic Congenital Heart Disease
Cyanotic Congenital Heart Disease
Pheochromocytoma
Paraganglioma

Interventions

Not provided

Countries

Slovenia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2019Actual

Primary Completion Date

May 31, 2021Estimated

Completion Date

Jun 9, 2021Estimated

First Submitted Date

May 10, 2021

First Submission Date that Met QC Criteria

May 13, 2021

First Posted Date

May 18, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2021

Last Update Posted Date

May 18, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mojca Jensterle, Clinical Professor, MD, PhD, University Medical Centre LjubljanaPrincipal Investigator

Lead Sponsor

University Medical Centre LjubljanaOTHER

Collaborators

Name	Class
University of Ljubljana, Faculty of Medicine	OTHER
University Rehabilitation Institute, Republic of Slovenia	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of our study is to compare plasma metanephrines in patients with cyanotic and acyanotic congenital heart disease and possible association with chronic hypoxic stress.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasma metanephrine level	Level of plasma metanephrine	baseline, one point of time in a cross-sectional study
Plasma normetanephrine level	Level of plasma normetanephrine	baseline, one point of time in a cross-sectional study

Secondary Outcomes

Measure	Description	Time Frame
Hypoxemia	Length of hypoxemia presence in years	baseline, one point of time in a cross-sectional study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with congenital heart disease attending regular follow up

Exclusion Criteria:

missing main data in medical documentation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients with congenital heart disease attending regular follow ups.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mojca Jensterle, MD, PhD	Contact	03861 522 35 64		mojca.jensterlesever@kclj.si

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Internal Medicine, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia	Recruiting	Ljubljana		1000	Slovenia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010673	Pheochromocytoma
D010235	Paraganglioma

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Patients with cyanotic Congenital Heart Disease
Patients with acyanotic Congenital Heart Disease