‘Intravenous iron treatment in iron deficient patients with pulmonary arterialhypertension' - Treating iron deficiency in PAH
- Conditions
- Objective: To evaluate the effects of intravenous iron suppletion in iron deficient IPAH patients.Study design: Intervention studyStudy population: Patients with idiopathic pulmonary arterial hypertension (IPAH) and iron deficiencyIntervention: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: 12.1Level: LLTClassification code 10064909Term: Idiopathic (IPAH)
- Registration Number
- EUCTR2010-023233-30-NL
- Lead Sponsor
- VU university medical center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 30
- Stable idiopathic pulmonary arterial hypertension (stable disease for at least 3 months)
- iron deficiency (serum iron below 10 µmol/l, decreased transferrin saturation (<15% in females and <20% in males) and serum ferritin <100 µg/l) irrespective of the coexistence of anaemia
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method