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…
ID
Source
Brief title
Condition
- Congenital cardiac disorders
- Cardiac and vascular disorders congenital
- Pulmonary vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Nowadays, biomarkers are broadly used in clinical practice. Blood-derived
biomarkers fulfil an important role in the field of cardiology. However, most
biomarkers have been investigated for adult left ventricular disease. In
congenital heart diseases (CHD) and pulmonary arterial hypertension (PAH),
which involves children and mostly the right ventricle, less is known about the
clinical and predictive value of blood-derived biomarkers. Since the group of
survivors of CHD and PAH is growing because of the improved techniques
nowadays, development of better tools to maintain the quality of life for the
longer term in these patients is urgently needed. Blood-derived biomarkers are
minimally invasive biomarkers, are quantitative and have shown to be able to
reveal pathological processes in an early stage. Hence, blood-derived
biomarkers may be a good addition to current diagnostic means in CHD and PAH.
Study objective
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.
Further, secondary (exploratory) objectives are to investigate the stability of
these blood-derived biomarkers in time and the interrelationship between these
blood-derived biomarkers. In addition,we will explore the predictive value of
these biomarkers measured at baseline with regard to clinically, relevant
impaired RV functioning parameters (RV-Fractional area change, RV-Fractional
shortening and RV function assessed with eyeballing) at long term follow-up.
Also, the predictive value of these biomarkers regarding clinical outcome,
defined as the composite of mortality, hospitalization, and or heart/lung
transplantation, will be investigated.These objectives will not only contribute
to the development of better diagnostic means, but could also result in
development of new targeted therapies for RV failure.
Study design
This study concerns a prospective, longitudinal observational cohort study.
Study burden and risks
In this study patient related information concerning baseline characteristics,
medical history, right ventricular function and partly information related to
collection of blood at baseline and follow up will be derived from standard
care. The additional burden of this study concerns drawing of extra volumes of
10 ml blood in patients at baseline and after one year. To assess biomarkers
three extra blood tubes (one lithium-heparin tube, one EDTA tube and one serum
tube) of 3 ml will be needed at both time points. The potential benefit of
participation for these patients with lifelong disease will be in the longer
term, as this study is intended to provide more insight into the value of these
new biomarkers in monitoring RV-function and predicting outcome. The results of
this study are expected to contribute to improve current available knowledge
regarding the underlying disease and to support treatment decisions and
goal-oriented treatment strategies in these patients.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | clinicaltrials.gov |
| CCMO | NL61433.042.17 |