A Phase 4 interventional study of Ferricarboxymaltose in Idiopathic Pulmonary Arterial Hypertension, sponsored by Amsterdam UMC, location VUmc. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-02-02.
Sponsored by Amsterdam UMC, location VUmc · Phase 4, Interventional, and Treatment
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.
352 studies on the registry are indexed under Familial Primary Pulmonary Hypertension; 35 are open to participants now.
This study's planned enrollment of 30 is below the median of 35 across 241 interventional studies indexed under Familial Primary Pulmonary Hypertension.
Browse Familial Primary Pulmonary Hypertension studies →Amsterdam UMC, location VUmc is the lead sponsor of 305 studies on the registry; 84 are open to participants now.
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Exclusion Criteria:
Ferricarboxymaltose (Ferinject®, Vifor Pharma) is used for intravenous iron administration. This iron is administered in high dose iron infusion of 1000 mg iron (equals 20 ml Ferinject) in 250 ml saline in the vein (infusion site)within 2 hours. During infusion, patients will be observed and blood pressure and heart rate are monitored before and after administration. Four weeks after iron administration, iron parameters are measured in the general practitioners setting. When iron parameters are still under normal values, a repeat infusion will be given of 500 mg iron (equals 10 ml Ferinject).
six-minute walking distance
The primary endpoint is improvement in six-minute walking distance
Time frame: 12 weeks
Serum iron parameters
Serum iron parameters and inflammatory parameters are measured
Time frame: 0 and 12 weeks
Exercise capacity
Cardiopulmonary exercise testing is performed to measure maximal exercise capacity and exercise endurance time.
Time frame: 0 and 12 weeks
Quadriceps muscle function
A biopsy from the quadriceps muscle is taken for histochemical analysis, myoglobin measurements and muscle fiber strength characteristics
Time frame: 0 and 12 weeks
Cardiac Function
A cardiac MRI is performed to measure cardiac function
Time frame: 0 and 12 weeks
Quality of life
Quality of life and NYHA functional class is established.
Time frame: 0 and 12 weeks
This study is status unknown, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.
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Familial Primary Pulmonary Hypertension →
Amsterdam UMC, location VUmc →