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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01288651
Other study ID # 2010-247
Secondary ID
Status Recruiting
Phase Phase 4
First received February 1, 2011
Last updated February 1, 2011
Start date January 2011
Est. completion date January 2013

Study information

Verified date January 2011
Source VU University Medical Center
Contact Gerrina Ruiter, MD
Phone +31 20 444 4915
Email G.Ruiter@vumc.nl
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date January 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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).

Locations

Country Name City State
Netherlands VUmc Amsterdam

Sponsors (2)

Lead Sponsor Collaborator
VU University Medical Center Vifor Pharma

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary six-minute walking distance The primary endpoint is improvement in six-minute walking distance 12 weeks No
Secondary Serum iron parameters Serum iron parameters and inflammatory parameters are measured 0 and 12 weeks No
Secondary Exercise capacity Cardiopulmonary exercise testing is performed to measure maximal exercise capacity and exercise endurance time. 0 and 12 weeks No
Secondary Quadriceps muscle function A biopsy from the quadriceps muscle is taken for histochemical analysis, myoglobin measurements and muscle fiber strength characteristics 0 and 12 weeks No
Secondary Cardiac Function A cardiac MRI is performed to measure cardiac function 0 and 12 weeks No
Secondary Quality of life Quality of life and NYHA functional class is established. 0 and 12 weeks No
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