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Plasma Metanephrines in Patients With Cyanotic and Acyanotic Congenital Heart Disease

Sponsor
University Medical Centre Ljubljana (Other)
Overall Status
Recruiting
CT.gov ID
NCT04891081
Collaborator
University of Ljubljana, Faculty of Medicine (Other), University Rehabilitation Institute, Republic of Slovenia (Other)
50
Enrollment
1
Location
19.3
Anticipated Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Plasma Metanephrines in Patients With Cyanotic and Acyanotic Congenital Heart Disease
    Actual Study Start Date :
    Nov 1, 2019
    Anticipated Primary Completion Date :
    May 31, 2021
    Anticipated Study Completion Date :
    Jun 9, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with cyanotic Congenital Heart Disease
    Patients with acyanotic Congenital Heart Disease

    Outcome Measures

    Primary Outcome Measures

    1. Plasma metanephrine level [baseline, one point of time in a cross-sectional study]

      Level of plasma metanephrine

    2. Plasma normetanephrine level [baseline, one point of time in a cross-sectional study]

      Level of plasma normetanephrine

    Secondary Outcome Measures

    1. Hypoxemia [baseline, one point of time in a cross-sectional study]

      Length of hypoxemia presence in years

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients with congenital heart disease attending regular follow up
    Exclusion Criteria:
    • missing main data in medical documentation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Internal Medicine, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia Ljubljana Slovenia 1000

    Sponsors and Collaborators

    • University Medical Centre Ljubljana
    • University of Ljubljana, Faculty of Medicine
    • University Rehabilitation Institute, Republic of Slovenia

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mojca Jensterle, Clinical Professor, MD, PhD, University Medical Centre Ljubljana
    ClinicalTrials.gov Identifier:
    NCT04891081
    Other Study ID Numbers:
    • 0000
    First Posted:
    May 18, 2021
    Last Update Posted:
    May 18, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pheochromocytoma
    Paraganglioma
    Heart Diseases
    Heart Defects, Congenital

    Study Results

    No Results Posted as of May 18, 2021