Iron Deficiency In Pulmonary Hypertension

NCT01288651 | Unknown Phase 4

• 1 other identifier: 2010-247
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Pulmonary Arterial Hypertension

Keywords

Pulmonary arterial hypertension; Iron deficiency; Exercise

Outcome Measures

Primary Outcomes (1)

• six-minute walking distance

  The primary endpoint is improvement in six-minute walking distance

  12 weeks

Secondary Outcomes (5)

• Serum iron parameters

  0 and 12 weeks

• Exercise capacity

  0 and 12 weeks

• Quadriceps muscle function

  0 and 12 weeks

• Cardiac Function

  0 and 12 weeks

• Quality of life

  0 and 12 weeks

Interventions

Ferricarboxymaltose DRUG

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• Vifor Pharma: collaborator

Study Sites (1)

VUmc

Amsterdam, Netherlands

RECRUITING

Related Publications (1)

• Ruiter G, Manders E, Happe CM, Schalij I, Groepenhoff H, Howard LS, Wilkins MR, Bogaard HJ, Westerhof N, van der Laarse WJ, de Man FS, Vonk-Noordegraaf A. Intravenous iron therapy in patients with idiopathic pulmonary arterial hypertension and iron deficiency. Pulm Circ. 2015 Sep;5(3):466-72. doi: 10.1086/682217.

  PMID: 26401247 DERIVED

MeSH Terms

Conditions

Familial Primary Pulmonary Hypertension; Pulmonary Arterial Hypertension; Iron Deficiencies; Motor Activity

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Study Officials

• Anton Vonk-Noordegraaf, Prof MD PhD

  VU University Medical Center, Deparment of Pulmonology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerrina Ruiter, MD

CONTACT

+31 20 444 4915; G.Ruiter@vumc.nl

Anton Vonk-Noordegraaf, Prof MD PhD

CONTACT

+31 20 444 4710; A.Vonk@vumc.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 1, 2011
• First Posted: February 2, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2013
• Last Updated: February 2, 2011

Record last verified: 2011-01

Locations

NL (1)