We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Iron Deficiency In Pulmonary Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01288651
Recruitment Status : Unknown
Verified January 2011 by Amsterdam UMC, location VUmc.
Recruitment status was:  Recruiting
First Posted : February 2, 2011
Last Update Posted : February 2, 2011
Vifor Pharma
Information provided by:
Amsterdam UMC, location VUmc

Brief Summary:

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

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Intervention Details:
  • Drug: Ferricarboxymaltose

    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).

Primary Outcome Measures :
  1. six-minute walking distance [ Time Frame: 12 weeks ]
    The primary endpoint is improvement in six-minute walking distance

Secondary Outcome Measures :
  1. Serum iron parameters [ Time Frame: 0 and 12 weeks ]
    Serum iron parameters and inflammatory parameters are measured

  2. Exercise capacity [ Time Frame: 0 and 12 weeks ]
    Cardiopulmonary exercise testing is performed to measure maximal exercise capacity and exercise endurance time.

  3. 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

  4. Cardiac Function [ Time Frame: 0 and 12 weeks ]
    A cardiac MRI is performed to measure cardiac function

  5. Quality of life [ Time Frame: 0 and 12 weeks ]
    Quality of life and NYHA functional class is established.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01288651

Layout table for location contacts
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

Layout table for location information
VUmc Recruiting
Amsterdam, Netherlands
Contact: Gerrina Ruiter, MD    +31 20 444 4915    G.Ruiter@vumc.nl   
Principal Investigator: Anton Vonk Noordegraaf, Prof MD PhD         
Sponsors and Collaborators
Amsterdam UMC, location VUmc
Vifor Pharma
Layout table for investigator information
Principal Investigator: Anton Vonk-Noordegraaf, Prof MD PhD VU University Medical Center, Deparment of Pulmonology
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: G. Ruiter, MD, VU university medical center, Department of Pulmonology
ClinicalTrials.gov Identifier: NCT01288651    
Other Study ID Numbers: 2010-247
First Posted: February 2, 2011    Key Record Dates
Last Update Posted: February 2, 2011
Last Verified: January 2011
Keywords provided by Amsterdam UMC, location VUmc:
Pulmonary arterial hypertension
Iron deficiency
Additional relevant MeSH terms:
Layout table for MeSH terms
Pulmonary Arterial Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases