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

Recruiting

Conditions: congenital heart disease
congenital heart defect
10010394
10007510
10037454

Registration Number: NL-OMON45378

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 380

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

- > 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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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