Iron Deficiency In Pulmonary Hypertension
|ClinicalTrials.gov Identifier: NCT01288651|
Recruitment Status : Unknown
Verified January 2011 by VU University Medical Center.
Recruitment status was: Recruiting
First Posted : February 2, 2011
Last Update Posted : February 2, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Pulmonary Arterial Hypertension||Drug: Ferricarboxymaltose||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intravenous Iron Treatment In Iron Deficient Patients With Idiopathic Pulmonary Arterial Hypertension|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||January 2013|
U.S. FDA Resources
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 [ Time Frame: 12 weeks ]The primary endpoint is improvement in six-minute walking distance
- Serum iron parameters [ Time Frame: 0 and 12 weeks ]Serum iron parameters and inflammatory parameters are measured
- Exercise capacity [ Time Frame: 0 and 12 weeks ]Cardiopulmonary exercise testing is performed to measure maximal exercise capacity and exercise endurance time.
- Quadriceps muscle function [ Time Frame: 0 and 12 weeks ]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 ]A cardiac MRI is performed to measure cardiac function
- Quality of life [ Time Frame: 0 and 12 weeks ]Quality of life and NYHA functional class is established.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|