Oral Iron Supplementation in Pulmonary Hypertension

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effects of iron supplementation in patients with pulmonary arterial hypertension and iron deficiency.

Detailed Description
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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.

Official Title
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Oral Iron Supplementation in Pulmonary Hypertension

Conditions
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Pulmonary Arterial Hypertension

Intervention / Treatment
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* Dietary Supplement: iron supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 21 and older diagnosis of idiopathic pulmonary arterial hypertension iron deficiency (transferrin saturation <20% and serum ferritin < 100 ug/l) Exclusion Criteria: active infection, malignancy, or bleeding hemochromatosis chronic inflammatory or autoimmune disease currently taking experimental/study medications, erythropoietin, iron supplementation, or immunosuppressants allergy to iron

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iron supplement<br>open-label iron supplement intervention group | Dietary Supplement: iron supplement<br>* 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.<br>* Other names: ferrous sulfate tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Zinc protoporphyrin from baseline |  | 3 months | 
| Change in serum ferritin from baseline |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum erythropoietin from baseline |  | 3 months | 
| Change in transferrin saturation from baseline |  | 3 months | 
| Change in %CD34+/133+ cells from baseline |  | 3 months | 
| Change in pulmonary arterial pressure from baseline | estimated using echocardiogram | 3 months | 
| Change in six minute walk distance from baseline |  | 3 months | 
| NYHA/WHO classification |  | 3 months | 
| Side effects of iron supplementation |  | 3 months | 
| Deaths and hospitalizations greater than 24 hours |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iron deficiency, pulmonary hypertension, iron supplements, ferrous sulfate