Idiopathic Pulmonary Arterial HypertensionPhase 4NCT01288651
Iron Deficiency In Pulmonary Hypertension
A Phase 4 study testing Ferricarboxymaltose in people with Idiopathic Pulmonary Arterial Hypertension, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Arterial Hypertension
- What is being tested?
- Ferricarboxymaltose
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2011to Jan 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
VUmc
Amsterdam
Gerrina Ruiter, MD, +31 20 444 4915, G.Ruiter@vumc.nl
Anton Vonk Noordegraaf, Prof MD PhD
About this study
Official title: Intravenous Iron Treatment In Iron Deficient Patients With Idiopathic Pulmonary Arterial Hypertension
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.
Read the 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.
- Being tested
- Ferricarboxymaltose
- Keywords
- Pulmonary arterial hypertension, Iron deficiency, Exercise
- Medical subject headings
- Familial Primary Pulmonary Hypertension, Pulmonary Arterial Hypertension, Iron Deficiencies, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FerricarboxymaltoseDrug
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
six-minute walking distance
The primary endpoint is improvement in six-minute walking distance
Measured: 12 weeks
Secondary outcomes (5)
Serum iron parameters
Serum iron parameters and inflammatory parameters are measured
Measured: 0 and 12 weeks
Exercise capacity
Cardiopulmonary exercise testing is performed to measure maximal exercise capacity and exercise endurance time.
Measured: 0 and 12 weeks
Quadriceps muscle function
A biopsy from the quadriceps muscle is taken for histochemical analysis, myoglobin measurements and muscle fiber strength characteristics
Measured: 0 and 12 weeks
Cardiac Function
A cardiac MRI is performed to measure cardiac function
Measured: 0 and 12 weeks
Quality of life
Quality of life and NYHA functional class is established.
Measured: 0 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2012 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Vifor Pharma
- Investigators
- Anton Vonk-Noordegraaf, Prof MD PhD, Principal investigator, VU University Medical Center, Deparment of Pulmonology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01288651
- Sponsor's protocol ID
- 2010-247
- Status last verified
- Jan 2011
- First submitted
- 1 Feb 2011
- Last updated
- 2 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26401247
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Iron Treatment In Iron Deficient Patients With Idiopathic Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT01288651
- Acronym / sponsor ID
- 2010-247
- Keywords
- Pulmonary arterial hypertension, Iron deficiency, Exercise
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Vifor Pharma
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 2 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FerricarboxymaltoseFerricarboxymaltose (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). | Drug | – |
Primary outcome
six-minute walking distance
Time frame: 12 weeks
The primary endpoint is improvement in six-minute walking distance
5 secondary outcomes
Serum iron parameters
Time frame: 0 and 12 weeks
Exercise capacity
Time frame: 0 and 12 weeks
Quadriceps muscle function
Time frame: 0 and 12 weeks
Cardiac Function
Time frame: 0 and 12 weeks
Quality of life
Time frame: 0 and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2011.
- Derived from this study: PubMed 26401247Ruiter 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anton Vonk-Noordegraaf, Prof MD PhD principal investigator
VU University Medical Center, Deparment of Pulmonology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferricarboxymaltose in people with Idiopathic Pulmonary Arterial Hypertension, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerrina Ruiter, MD (+31 20 444 4915, G.Ruiter@vumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
six-minute walking distance (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01288651, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2011.