DRKS00032944招募中不适用

Iron (mal)absorption in pulmonary arterial hypertension patients

Thoraxklinik am Universitätsklinikums Heidelberg - Zentrum für pulmonale Hypertonie0 个研究点目标入组 30 人开始时间: 2023年11月9日最近更新: 2024年8月19日

适应症

试验速览

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•Patients, diagnosed with heritable PAH, idiopathic PAH, drug and toxin associated PAH (PAH), PAH associated with congenital heart disease with simple heart defects (such as ventricle septal defect, atrial septal defect, patent ductus arteriosus and patent foramen ovale), PAH with comorbidities not affecting iron metabolism or microbiome
•Baseline haemodynamics showing mPAP >20 mmHg at rest, PVR >2 WU, PAWP =15 mmHg
•Optimized, unchanged targeted PAH therapy since at least 2 months
•Ability to understand and willing to sign the informed consent form

•Patients with connective tissue disease associated PAH (gastrointestinal bleeding cannot be excluded in these patients)
•Patients with Morbus Osler associated PAH (gastrointestinal bleeding cannot be excluded in these patients)
•Pregnancy or lactation
•Malignancy
•Severe kidney disease with glomerular filtration rate <30 ml/min
•Severe liver injury as indicated by aminotransferases >3x upper limit of normal or bilirubin levels >50 µmol/l (equivalent to >2.9 mg/dl)
•Intravenous or oral iron supplementation within the preceding 2 months
•Patients with prior determined transferrin saturation >90% as plasma iron is not expected to rise in these patients (Kobune et al., 2011)
•Comorbidities affecting iron metabolism such as haemolytic anaemias, genetic disorders of haemoglobin, diabetes, sickle cell disease, thalassemia or any known iron overload syndrome
•Comorbidities affecting the gut microbiome such as inflammatory bowel disease, Crohn’s disease or other gastrointestinal diseases
•Acute infection in the past 2 weeks
•Intake of antibiotics in the past 2 weeks
•Any haemolytic samples will be disregarded as iron values can be falsely elevated

发起方

Thoraxklinik am Universitätsklinikums Heidelberg - Zentrum für pulmonale Hypertonie