Iron Deficiency In Pulmonary Hypertension
Recruitment status was Recruiting
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.
Idiopathic Pulmonary Arterial Hypertension
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Intravenous Iron Treatment In Iron Deficient Patients With Idiopathic Pulmonary Arterial Hypertension|
- six-minute walking distance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The primary endpoint is improvement in six-minute walking distance
- Serum iron parameters [ Time Frame: 0 and 12 weeks ] [ Designated as safety issue: No ]Serum iron parameters and inflammatory parameters are measured
- Exercise capacity [ Time Frame: 0 and 12 weeks ] [ Designated as safety issue: No ]Cardiopulmonary exercise testing is performed to measure maximal exercise capacity and exercise endurance time.
- Quadriceps muscle function [ Time Frame: 0 and 12 weeks ] [ Designated as safety issue: No ]A biopsy from the quadriceps muscle is taken for histochemical analysis, myoglobin measurements and muscle fiber strength characteristics
- Cardiac Function [ Time Frame: 0 and 12 weeks ] [ Designated as safety issue: No ]A cardiac MRI is performed to measure cardiac function
- Quality of life [ Time Frame: 0 and 12 weeks ] [ Designated as safety issue: No ]Quality of life and NYHA functional class is established.
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||January 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
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).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01288651
|Contact: Gerrina Ruiter, MD||+31 20 444 4915||G.Ruiter@vumc.nl|
|Contact: Anton Vonk-Noordegraaf, Prof MD PhD||+31 20 444 4710||A.Vonk@vumc.nl|
|Contact: Gerrina Ruiter, MD +31 20 444 4915 G.Ruiter@vumc.nl|
|Principal Investigator: Anton Vonk Noordegraaf, Prof MD PhD|
|Principal Investigator:||Anton Vonk-Noordegraaf, Prof MD PhD||VU University Medical Center, Deparment of Pulmonology|