Iron Deficiency In Pulmonary Hypertension

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by VU University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Vifor Pharma
Information provided by:
VU University Medical Center
ClinicalTrials.gov Identifier:
NCT01288651
First received: February 1, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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 Intervention Phase
Idiopathic Pulmonary Arterial Hypertension
Drug: Ferricarboxymaltose
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by VU University Medical Center:

Primary Outcome Measures:
  • six-minute walking distance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The primary endpoint is improvement in six-minute walking distance


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 30
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)
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288651

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

Locations
Netherlands
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
VU University Medical Center
Vifor Pharma
Investigators
Principal Investigator: Anton Vonk-Noordegraaf, Prof MD PhD VU University Medical Center, Deparment of Pulmonology
  More Information

No publications provided

Responsible Party: G. Ruiter, MD, VU university medical center, Department of Pulmonology
ClinicalTrials.gov Identifier: NCT01288651     History of Changes
Other Study ID Numbers: 2010-247
Study First Received: February 1, 2011
Last Updated: February 1, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by VU University Medical Center:
Pulmonary arterial hypertension
Iron deficiency
Exercise

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014