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| Name | Class |
|---|---|
| UZ Leuven, Leuven, Belgium | UNKNOWN |
| UCL Bruxelles | UNKNOWN |
| Lund University Hospital | OTHER |
| University Hospital Schleswig-Holstein |
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This European multicenter observational study aims to evaluate the real-world use, timing, and outcomes of lymphatic interventions in patients with congenital heart disease and/or primary lymphatic disorders. The study will examine the effectiveness of diagnostic imaging and interventional techniques, such as lymphatic embolization, in improving clinical symptoms, biomarkers, and fluid-related complications. The central question is whether early diagnosis and targeted intervention can lead to clinically meaningful improvements and reduced need for reintervention. Data collected retrospectively and prospectively from participating centers will help identify predictors of outcome, assess disease severity, and inform standardized diagnostic and therapeutic pathways across Europe.
This is a prospective, multicenter observational study with retrospective components. The study population includes patients who have undergone or are undergoing lymphatic imaging diagnostics and lymphatic interventions at participating centers across Europe. Patients are included both retrospectively (from medical records) and prospectively as part of their routine clinical care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lymph intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lymphatic intervention | Procedure | This intervention was made as part of their clinical treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Symptoms Following Lymphatic Intervention, assessed by: | Patient-reported or physician-assessed symptoms (e.g., cough, diarrhea, dyspnea) will be categorized as normalized, improved, unchanged, or worsened compared to baseline. Unit of Measure: Symptom status category (normalized / improved / unchanged / worsened) | From time of treatment to yearly follow-up up to 5 years. |
| Change in Objective Biomarkers Following Lymphatic Intervention | Objective clinical findings (e.g., serum albumin level, lymphocyte count, fluid accumulation) will be categorized as normalized, improved, unchanged, or worsened compared to baseline. Unit of Measure: Biomarker status category (normalized / improved / unchanged / worsened) | From time of treatment to yearly follow-up up to 5 years. |
| Composite improvement: | ≥50% reduction in presenting symptoms and/or ≥20% improvement in key biomarkers (e.g., serum albumin, lymphocyte count etc.). | From time of treatment to yearly follow-up up to 5 years. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be identified from pediatric and adult congenital cardiology and lymphatic referral centers across Europe. The study population includes patients of any age with congenital heart disease (CHD) and associated central lymphatic complications (such as plastic bronchitis, protein-losing enteropathy, or chylothorax), as well as patients with primary central lymphatic disorders. Patients are included from tertiary care institutions that perform lymphatic imaging and/or interventions and will be enrolled retrospectively from existing clinical records and prospectively during routine care.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sanam Safi-Rasmussen, MD | Contact | +4530490641 | sanam.safi-rasmussen@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Vibeke E Hjortdal, Professor | Rigshospitalet, Denmark | Study Director |
| Michael Rahbek Schmidt, Ass. professor, PhD, DMSc | Rigshospitalet, Denmark | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet, Copenhagen University Hospital | Recruiting | Copenhagen | 2100 | Denmark |
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| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D011504 | Protein-Losing Enteropathies |
| D002916 | Chylothorax |
| D044148 | Lymphatic Abnormalities |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| OTHER |
| University Hospital, Aachen | OTHER |
| Deutsches Herzzentrum Muenchen | OTHER |
| Universitätsklinikum Erlangen, Erlangen, Bayern, Germany | UNKNOWN |
| UZ Gent, Belgium | UNKNOWN |
| Hospital for Children and Adolescents, University of Helsinki | UNKNOWN |
| Hospital Universitari Vall d'hebron Barcelona, Spain | UNKNOWN |
| Children's University Hospital, Ireland | OTHER |
| Evelina London Children's Hospital | UNKNOWN |
| Guy's and St Thomas' NHS Foundation Trust | OTHER |
| Bambin Gesù Hospital IRCCS, Rome, Italy | UNKNOWN |
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| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |