Pulmonary Arterial HypertensionNCT01446848
Oral Iron Supplementation in Pulmonary Hypertension
A study testing iron supplement in people with Pulmonary Arterial Hypertension, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effects of iron supplementation in patients with pulmonary arterial hypertension and iron deficiency. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- iron supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Aug 2014
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 21 and older
- diagnosis of idiopathic pulmonary arterial hypertension
- iron deficiency (transferrin saturation <20% and serum ferritin < 100 ug/l)
Who cannot join
- active infection, malignancy, or bleeding
- hemochromatosis
- chronic inflammatory or autoimmune disease
- currently taking experimental/study medications, erythropoietin, iron supplementation, or immunosuppressants
- allergy to iron
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the effects of iron supplementation in patients with pulmonary arterial hypertension and iron deficiency.
Read the detailed description
Pulmonary arterial hypertension (PAH) is a chronic disease associated with upregulation of hypoxia inducible-factor-1alpha (HIF-1alpha) and functional iron deficiency. The investigators are proposing a prospective, single-arm, open-label intervention to determine whether oral iron supplementation in patients with pulmonary arterial hypertension reduces markers of HIF activation and improve clinical parameters of disease. After the baseline visit, patients will be given ferrous sulfate tablets to take orally for 3 months. Outcome data will be collected at the baseline visit and at the end of the 3-month study period.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- iron supplement
- Keywords
- iron deficiency, pulmonary hypertension, iron supplements, ferrous sulfate
- Medical subject headings
- Pulmonary Arterial Hypertension, Iron Deficiencies, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iron supplementDietary supplement
Also called ferrous sulfate tablets
325 mg tablets by mouth once a day for 1 week, then twice a day for 1 week, then three times daily for the remainder of the 3-month study period.
| Study group | Role | What they receive |
|---|---|---|
| iron supplement | Experimental | open-label iron supplement intervention group Receives: Dietary Supplement: iron supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Zinc protoporphyrin from baseline
Measured: 3 months
Change in serum ferritin from baseline
Measured: 3 months
Secondary outcomes (8)
Change in serum erythropoietin from baseline
Measured: 3 months
Change in transferrin saturation from baseline
Measured: 3 months
Change in %CD34+/133+ cells from baseline
Measured: 3 months
Change in pulmonary arterial pressure from baseline
estimated using echocardiogram
Measured: 3 months
Change in six minute walk distance from baseline
Measured: 3 months
NYHA/WHO classification
Measured: 3 months
Side effects of iron supplementation
Measured: 3 months
Deaths and hospitalizations greater than 24 hours
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startJan 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Farha, MD, The Cleveland Clinic
- Investigators
- Samar Farha, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446848
- Sponsor's protocol ID
- RPC-2011-1026
- Status last verified
- Aug 2014
- First submitted
- 3 Oct 2011
- Last updated
- 12 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Iron Supplementation in Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT01446848
- Acronym / sponsor ID
- RPC-2011-1026
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- iron deficiency, pulmonary hypertension, iron supplements, ferrous sulfate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 5 Oct 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.
The purpose of this study is to investigate the effects of iron supplementation in patients with pulmonary arterial hypertension and iron deficiency.
Detailed description
Pulmonary arterial hypertension (PAH) is a chronic disease associated with upregulation of hypoxia inducible-factor-1alpha (HIF-1alpha) and functional iron deficiency. The investigators are proposing a prospective, single-arm, open-label intervention to determine whether oral iron supplementation in patients with pulmonary arterial hypertension reduces markers of HIF activation and improve clinical parameters of disease. After the baseline visit, patients will be given ferrous sulfate tablets to take orally for 3 months. Outcome data will be collected at the baseline visit and at the end of the 3-month study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iron supplement | Experimental | Dietary Supplement: iron supplementopen-label iron supplement intervention group |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 21 and older
- diagnosis of idiopathic pulmonary arterial hypertension
- iron deficiency (transferrin saturation <20% and serum ferritin < 100 ug/l)
Key exclusion criteria (5 listed)
- active infection, malignancy, or bleeding
- hemochromatosis
- chronic inflammatory or autoimmune disease
- currently taking experimental/study medications, erythropoietin, iron supplementation, or immunosuppressants
- allergy to iron
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 |
|---|---|---|
| iron supplementAlso: ferrous sulfate tablets325 mg tablets by mouth once a day for 1 week, then twice a day for 1 week, then three times daily for the remainder of the 3-month study period. | Dietary supplement | iron supplement |
Primary outcome
Change in Zinc protoporphyrin from baseline
Time frame: 3 months
Change in serum ferritin from baseline
Time frame: 3 months
8 secondary outcomes
Change in serum erythropoietin from baseline
Time frame: 3 months
Change in transferrin saturation from baseline
Time frame: 3 months
Change in %CD34+/133+ cells from baseline
Time frame: 3 months
Change in pulmonary arterial pressure from baseline
Time frame: 3 months
Change in six minute walk distance from baseline
Time frame: 3 months
NYHA/WHO classification
Time frame: 3 months
Side effects of iron supplementation
Time frame: 3 months
Deaths and hospitalizations greater than 24 hours
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2014.
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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.
Samar Farha, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iron supplement in people with Pulmonary Arterial Hypertension, run by The Cleveland Clinic at 1 site in United States.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 12 Aug 2014. 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 United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Zinc protoporphyrin from baseline (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2014.