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Correlation of Longitudinal Biomarkers with Right Ventricular Function in Congenital Heart Diseases and Pulmonary Arterial Hypertension

Correlation of Longitudinal Biomarkers with Right Ventricular Function in Congenital Heart Diseases and Pulmonary Arterial Hypertension - Biomarkers CHD PAH

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON45378
Enrollment
380
Registered
2017-10-31
Start date
2017-12-05
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

congenital heart disease

Interventions

biomarker
congenital heart diseases
pulmonary arterial hypertension

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

Inclusion criteria: In this study we will include patients aged 0-18 years with a (history of) pressure- and/or volume-loaded right ventricle due to congenital heart disease and/or pulmonary arterial hypertension, seen in the University Medical Centre Groningen-Centre for Congenital Heart Diseases (UMCG-CCH) between 01-09-2017 and 01-09-2021.

Exclusion criteria

Exclusion criteria: - > 18 years of age - no echocardiography within three months before or after blood collection - pregnant - concomitant musculoskeletal disease - being under examination for non-diagnosed disease at time of investigation

Design outcomes

Primary

MeasureTime frame
Our primary objective is to investigate cross-sectionally the association between various emerging blood-derived biomarkers and right ventricular (RV) function:defined as tricuspid annular plane systolic excursion (TAPSE) measured with echocardiography, in children with (a history of ) an abnormally loaded, volume and/or pressure loaded, right ventricle associated with CHD and/or PAH.

Secondary

MeasureTime frame
Secondary (exploratory) Objective(s): Furthermore, we aim to explore: - The stability, dynamic (treatment-induced) longitudinal changes of these biomarkers and their association with RV function (defined as TAPSE). - The predictive value of these biomarkers measured at baseline with regard to various clinically relevant impaired RV functioning parameters (TAPSE, RV- Fractional area change , RV-Fractional shortening and RV function assessed with eyeballing) at long term follow-up. - The predictive value of these biomarkers with regard to clinical outcome defined as the composite of mortality, hospitalization, and or heart/lung transplantation.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)