Pulmonary Arterial Hypertension
Conditions
Keywords
iron deficiency, pulmonary hypertension, iron supplements, ferrous sulfate
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTiron supplement
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.
Sponsors
The Cleveland Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Zinc protoporphyrin from baseline | 3 months |
| Change in serum ferritin from baseline | 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in %CD34+/133+ cells from baseline | 3 months | — |
| Change in pulmonary arterial pressure from baseline | 3 months | estimated using echocardiogram |
| Change in six minute walk distance from baseline | 3 months | — |
| Change in serum erythropoietin from baseline | 3 months | — |
| Side effects of iron supplementation | 3 months | — |
| Deaths and hospitalizations greater than 24 hours | 3 months | — |
| NYHA/WHO classification | 3 months | — |
| Change in transferrin saturation from baseline | 3 months | — |
Countries
United States
Outcome results
None listed