Objective: To evaluate the effects of intravenous iron suppletion in iron deficient IPAH patients. Study design: Intervention study Study population: Patients with idiopathic pulmonary arterial hypertension (IPAH) and iron deficiency Intervention: Patients receive a weekly iron bolus infusion until iron levels are restored (correction phase). Then a maintenance dose is given once per month (maintenance phase) until the endpoint after 20 weeks. MedDRA version: 12.1 Level: LLT Classification code
Conditions
Interventions
Trade Name: Ferinject
Product Name: Ferric carboxymaltose
Product Code: RVG 33865
Pharmaceutical Form: Solution for injection
Sponsors
VU university medical center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Stable idiopathic pulmonary arterial hypertension (stable disease for at least 3 months) - iron deficiency (serum iron below 10 µmol/l, decreased transferrin saturation (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Current iron therapy (oral or iv) - Current other study medication for PAH - History of anaemia or current treatment of anaemia - Liver function impairment - Chronic disease other than PAH ( rheumatism, asthma, chronic infection) - Acute infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effects of intravenous iron suppletion in iron deficient IPAH patients.;Secondary Objective: To observe the effects of intravenous iron suppletion on exercise capacity in IPAH patients;Primary end point(s): Effects on six-minute walking distance tests of intravenous iron. | — |
Countries
Netherlands
Outcome results
None listed