Biomarkers in Congenital Heart Diseases and Pulmonary Arterial Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- TAPSE (mm) TAPSE (tricuspid annular plane systolic excursion)
研究概览
简要总结
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.
Objective: The primary objective of this study 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.
详细描述
OBJECTIVES:
Primary Objective:
The primary objective is to investigate cross-sectionally (at baseline and after one year) 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.
TIME FRAME: Baseline and after one year.
Secondary Objective:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 0-18 years
- •Patients with Pulmonary Arterial hypertension: diagnosis confirmed according to the standards of the National Expertise Center for PH in childhood.
- •Patients with CHD with an abnormally loaded right ventricle including tetralogy of Fallot (TOF), pulmonary (valve) stenosis (PS), pulmonary insufficiency (PI), atrial septal defect (ASD), ventricular septal defect (VSD) and total anomalous pulmonary venous return (TAPVR): diagnosis confirmed by echocardiography or cardiac MRI in UMCG-CCH.
排除标准
- •Age >18 years
- •Not familiar with Dutch language
- •Concomitant musculoskeletal disease
- •No echocardiography available within three months before or after blood collection
- •Being under examination for non-diagnosed disease at time of investigation
结局指标
主要结局
TAPSE (mm) TAPSE (tricuspid annular plane systolic excursion)
时间窗: At baseline (t=0)
Right ventricular function defined as TAPSE assessed by echocardiography
次要结局
- WHO functional class(At 1 year)
- Six-minute walk distance (6MWD)(At 1 year)
- RV fractional area change (RV-FAC)(At 1 year)
- RV fractional shortening (RV-FS)(At 1 year)
- RV-function assessed with eyeballing (good, moderate, bad)(At 1 year)
- NYHA classification(At 1 year)
研究者
Prof. dr. R.M.F. Berger
Head of Pediatric Cardiology
University Medical Center Groningen