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Iron (mal)absorption in pulmonary arterial hypertension patients

Recruiting
Conditions
I27.0
Primary pulmonary hypertension
Registration Number
DRKS00032944
Lead Sponsor
Thoraxklinik am Universitätsklinikums Heidelberg - Zentrum für pulmonale Hypertonie
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
30
Inclusion Criteria

•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

Exclusion Criteria

•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
•Diarrhoea
•Any haemolytic samples will be disregarded as iron values can be falsely elevated

Study & Design

Study Type
observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To assess the difference in iron absorption in PAH patients with and without recurrent iron deficiency measured by a standardized iron absorption test
Secondary Outcome Measures
NameTimeMethod
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