Plasma Metanephrines in Patients With Cyanotic and Acyanotic Congenital Heart Disease

May 13, 2021 updated by: Mojca Jensterle, University Medical Centre Ljubljana
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Recruiting
        • Department of Internal Medicine, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with congenital heart disease attending regular follow ups.

Description

Inclusion Criteria:

  • patients with congenital heart disease attending regular follow up

Exclusion Criteria:

  • missing main data in medical documentation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with cyanotic Congenital Heart Disease
Patients with acyanotic Congenital Heart Disease

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Collaborators

University Rehabilitation Institute, Republic of Slovenia
University of Ljubljana, Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Anticipated)

May 31, 2021

Study Completion (Anticipated)

June 9, 2021

Study Registration Dates

First Submitted

May 10, 2021

First Submitted That Met QC Criteria

May 13, 2021

First Posted (Actual)

May 18, 2021

Study Record Updates

Last Update Posted (Actual)

May 18, 2021

Last Update Submitted That Met QC Criteria

May 13, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0000 (Centre for care Science, KI, Norrbacka Eugeniastiftelsen)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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