Idiopathic Pulmonary Arterial Hypertension Clinical Trial
Official title:
Intravenous Iron Treatment In Iron Deficient Patients With Idiopathic Pulmonary Arterial Hypertension
Patients with idiopathic pulmonary arterial hypertension (IPAH) and iron deficiency were
previously shown to have a decreased six-minute walking distance. Therefore the
investigators hypothesized that intravenous iron administration would improve exercise
capacity in iron deficient IPAH patients.
30 patients will be recruited for iron infusions. At baseline and after 12 weeks
(endpoint)exercise test will be performed.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | January 2013 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 (< 15% in females and < 20% in males) and serum ferritin < 100 µg/l) irrespective of the coexistence of anaemia Exclusion Criteria: - Current iron therapy (oral or iv) - Current other study medication for PAH - History of anaemia or current treatment for anaemia - Liver function impairment - Chronic disease other than PAH (rheumatism, asthma, chronic infection) - Acute infection |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | VUmc | Amsterdam |
Lead Sponsor | Collaborator |
---|---|
VU University Medical Center | Vifor Pharma |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | six-minute walking distance | The primary endpoint is improvement in six-minute walking distance | 12 weeks | No |
Secondary | Serum iron parameters | Serum iron parameters and inflammatory parameters are measured | 0 and 12 weeks | No |
Secondary | Exercise capacity | Cardiopulmonary exercise testing is performed to measure maximal exercise capacity and exercise endurance time. | 0 and 12 weeks | No |
Secondary | Quadriceps muscle function | A biopsy from the quadriceps muscle is taken for histochemical analysis, myoglobin measurements and muscle fiber strength characteristics | 0 and 12 weeks | No |
Secondary | Cardiac Function | A cardiac MRI is performed to measure cardiac function | 0 and 12 weeks | No |
Secondary | Quality of life | Quality of life and NYHA functional class is established. | 0 and 12 weeks | No |
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