NCT04891081

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.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2019

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

November 1, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 18, 2021

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2021

Completed
Last Updated

May 18, 2021

Status Verified

May 1, 2021

Enrollment Period

1.6 years

First QC Date

May 10, 2021

Last Update Submit

May 13, 2021

Conditions

Acyanotic Congenital Heart DiseaseCyanotic Congenital Heart DiseasePheochromocytomaParaganglioma

Outcome Measures

Primary Outcomes (2)

  • 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 (1)

  • Hypoxemia

    baseline, one point of time in a cross-sectional study

Study Arms (2)

Patients with cyanotic Congenital Heart Disease

Patients with acyanotic Congenital Heart Disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with congenital heart disease attending regular follow ups.

You may qualify if:

  • patients with congenital heart disease attending regular follow up

You may not qualify if:

  • missing main data in medical documentation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

PheochromocytomaParaganglioma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Central Study Contacts

Mojca Jensterle, MD, PhD

CONTACT

03861 522 35 64mojca.jensterlesever@kclj.si

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor, MD, PhD

Study Record Dates

First Submitted

May 10, 2021

First Posted

May 18, 2021

Study Start

November 1, 2019

Primary Completion

May 31, 2021

Study Completion

June 9, 2021

Last Updated

May 18, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)