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.
Background: Patients with pulmonary arterial hypertension (PAH) develop progressive right
heart failure which eventually will lead to death. During progression of the disease the
physical performance of the patients deteriorates. Maintaining their exercise capacity is a
major goal in PAH treatment. Iron treatment is known to have a positive effect on physical
performance in patients with left heart failure and iron deficiency. Whether this is also
effective in patients with right heart failure (PAH) and iron deficiency is until now
unknown.
Objective: To evaluate the effects of intravenous iron supplementation on exercise capacity
in iron deficient IPAH patients.
Study design: Intervention study
Study population: Patients with idiopathic pulmonary arterial hypertension (IPAH) and iron
deficiency
Patients receive an iron bolus infusion of 1000 mg iron after baseline measurements.
Main study parameters/endpoints:
Primary endpoint: six minute walking distance (6WMD) Secondary endpoints: cardiopulmonary
exercise test, myoglobin concentration in quadriceps muscle, quadriceps muscle fiber
strength, serum iron parameters, serum inflammatory parameters, quality of life (QOL), and
NYHA functional class.
The patients will be hospitalised two days at the beginning and two days at the end of the
study to perform the exercise and strength tests, six minute walking distance and for biopsy
of the quadriceps muscle. Also NYHA functional class will be determined and a QOL
questionnaire has to be filled in. After the baseline measurements an iron infusion will be
given (Ferinject 1000mg).
The investigators hypothesize that iron deficient IPAH patients will benefit from iron
treatment with improved exercise capacity reflected in an increased 6MWD.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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